Hemodynamic InstabilityPhase 4NCT05877131
Evaluate Efficacy Levobupivacaine 0.125% Versuss Ropivacaine 0.2% in Hemodynamic Alterations in Labor and Fetal Repercussions
A Phase 4 study testing Levobupivacaine and Ropivacaine in people with Hemodynamic Instability and Epidural, run by Althaia Xarxa Assistencial Universitària de Manresa at 1 site in Spain.
Trial summary
INTRODUCTION: Most studies on analgesia in pregnant women in labor mainly evaluate the effect of anesthetics on pain, mentioning hypotension as a side effect without investigating its impact on fetal well-being. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Hemodynamic Instability, Epidural, Pregnancy
- What is being tested?
- Levobupivacaine and Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2023to 1 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- - Woman > 18 years
- Request epidural anesthesia (EA)
- Expansion period
- Low obstetric risk
- ASA I-II (only one associated comorbidity, example: arterial hypertension, etc.)
- Cervix dilation ≥ 3
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- single fetus
- Gestational age > 36 weeks
- Normal Fetal Heart Rate (110 -160 beats / minute)
- Normal Cardiotocographic record or absence of fetal heart rate patterns suggestive of risk of loss of fetal well-being or non-reassuring cardiotocographic record.
Who cannot join
- VAS ≤ 2
- Breech presentation
- Maternal fever > 38 years
- Pre-eclampsia and severe eclampsia
- Prenatal bleeding
- ASA II (more than one comorbidity)
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- Chronic pain
- Substance abuse
- Contraindications for epidural analgesia (EA)
- Allergy to local anesthetics
- BMI >40 kg/m²
- Presence of RCTG not reassuring
Trial locations and contacts
1 site in 1 country.
Susana Gonzalez Suarez contact
Spain1 site
Althaia Xarxa Assitensial i Universitaria Manresa
Manresa, Barcelona, 08243
Anna Arnau Bartes, Epidemiologist, 0034938759300 ext. 3414, aarnau@althaia.cat
About this study
Official title: Randomized Clinical Trial to Evaluate the Efficacy of Levobupivacaine 0.125% vs Ropivacaine 0.2%, in Hemodynamic Alterations in Pregnant Women in Labor and Their Fetal Repercussions
INTRODUCTION:
Most studies on analgesia in pregnant women in labor mainly evaluate the effect of anesthetics on pain, mentioning hypotension as a side effect without investigating its impact on fetal well-being. The objective of the present study is to evaluate the efficacy of the use of low doses of local anesthetic (LA) to prevent hemodynamic alterations that manifest as a loss of fetal well-being.
Read more
METHODOLOGY/DESIGN:
It is a randomized clinical trial. Patients will be pregnant women in labor (dilation period) who want epidural anesthesia (EA), who will randomly receive 0.125% levobupivacaine (Group L) versus 0.2% ropivacaine (Group R). In both groups, controls of hemodynamic parameters and their relationship with changes in fetal heart rate (FHR) and cardiotocographic recording (RCTG) will be carried out during the first 60 minutes after the administration of the local anesthetic via the epidural route. In case of hypotension and/or subsequent FHR and RCTG alterations, they will also be recorded. The follow-up period will extend from the moment the patient enters the delivery room and requests epidural anesthesia until the moment the patient is discharged from the delivery room. The percentage of patients with hemodynamic alterations will be evaluated as a primary result, as well as the percentage of patients whose hemodynamic alterations are related to changes in FHR and RCTG, when using low doses of LA. In the following will also be evaluated in relation to analgesia, the onset time, level reached and degree of satisfaction; and various intra and postpartum side effects.
DISCUSSION:
Both groups of pregnant women in labor will be studied in order to obtain data on the potential impact of the use of low doses of local anesthetic via the epidural route on hemodynamic parameters and the state of well-being of the fetus.
Read the detailed description
Any patient presenting in the delivery room or gynecology-obstetrics office of the hospital with prodromes, midwives or gynecologists will inform the principal investigator (PI). The IP will contact the patient to inform them of what the study consists of and if they wish to participate in it. In case of acceptance, the explanatory documentation and a questionnaire will be delivered to determine if it meets the inclusion criteria. If the pregnant patient at term meets the inclusion criteria, she is recruited to enter the study, it will also be used to resolve any doubts that the patient may have. Once the patient has signed the informed consent, the collaborating researcher (CI) of the recruiting center will be notified to contact the Althaia Innovation and Research Unit to find out the patient's assignment group. The collaborating researcher will be in charge of notifying the patient of the group to which she has been assigned (Intervention Group A or B).
Initially, the basal hemodynamic constants will be recorded: systolic blood pressure (SBP), mean blood pressure (TAM), diastolic blood pressure (TAD), pulse pressure (PP), systemic vascular resistance (SVR), cardiac output (CO), index Pulse Pressure Variation (PPV), Stroke Volume Variation (SVV), Heart Rate (HR), Stroke Volume (SV), Partial Pressure Oxygen Saturation (SpO2) via Clearsight device ®; pain score (VAS); degree of anxiety/depression by filling in a questionnaire to complete yourself; the degree of dilation. The FHR will also be recorded, as well as the different pathological patterns of the RCTG that appear, the Philips Avalon FM 30 monitor will be used for this.
The steps to follow for the administration of local anesthetic through the epidural catheter will be the following:
The mother's data (before and after AE) will be collected, including hemodynamic data: systolic blood pressure (SBP), mean blood pressure (TAM), diastolic blood pressure (TAD), pulse pressure (PP), vascular resistance heart rate (SVR), cardiac output (CO), cardiac index (CI), pulse pressure variation (PPV), stroke volume variation (VSV), heart rate (HR), stroke volume (SV), blood saturation partial pressure of oxygen (SpO2); pain score (VAS), degree of analgesia achieved, satisfaction obtained, time onset of analgesia, level of sensory block using the pin-prick test and the hot-cold test; degree of anxiety/depression by filling in a questionnaire to complete yourself; the degree of dilation. The fetal data (before and after the AE) of the FHR (values above or below the normal limits) will also be included, as well as the different pathological patterns of the RCTG that appear, due to hypotension or alterations. associated hemodynamics.
All pregnant women who will participate in this study will carry an intravenous cannula and will receive a fluid load of 500 cc. The position of the patients will be in a sitting position and the epidural puncture will be performed at the level of the L2-3 or L3-4 intervertebral space using a Tuohy 18 epidural needle. The loss of resistance technique with air or saline will be used according to the standards of our service.
A volume of 2 ml of 2% lidocaine will be administered via the epidural via the epidural catheter, after 3 minutes (it will be evaluated if undesirable effects appear: such as motor block due to accidental dural puncture, hypotension, nausea, vomiting), it will be administered to pregnant women the final volume (10 cc) of the local anesthetic randomly assigned via epidural.
After the administration of the initial bolus (Group A - Group B), the different constants or parameters to be evaluated will be recorded.
The measurement of the different hemodynamic variables will be recorded through a non-invasive device, the Clearsight®. The device will automatically determine the constants, which will be recorded at 5, 10, 15, 30, 45 and 60 minutes.
In the event of recording an episode of hypotension after the first 60 minutes, a record of all the hemodynamic variables evaluated will be made every 5 minutes for the following 60 minutes.
It will be determined which of the local anesthetics at low concentrations administered via the epidural is related to alteration of the hemodynamic parameters. To measure the different parameters, a non-invasive device (Clearsight) will be used, which will determine the existing hemodynamic alterations before, after, and during the first hour after the administration of the initial dose through the lumbar epidural catheter, as well as in the event of an episode. of hypotension or changes in FHR and/or RCTG after the first hour of catheter placement.
- Conditions
- Hemodynamic Instability, Epidural, Pregnancy, Fetal Cardiac Disorder
- Being tested
- Levobupivacaine, Ropivacaine
- Keywords
- Hemodynamic instability, Epidural, Pregnancy, Fetal Cardiac disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
To evaluate the efficacy of low-dose levobupivacaine (0.125%) (0.2) in avoiding hemodynamic changes after performing regional analgesia in pregnant women in labor and preventing changes in fetal heart rate and cardiotocographic recording.
RopivacaineDrug
To evaluate the efficacy of low-dose ropivacaine (0.2) in avoiding hemodynamic changes after performing regional analgesia in pregnant women in labor and preventing changes in fetal heart rate and cardiotocographic recording.
| Study group | Role | What they receive |
|---|---|---|
| Levobupivacaina | Active comparator | Levobupivacaine 0.125% , dosage 10 ml frequency 1 one dosis duration 1 hour Receives: Drug: Levobupivacaine |
| Ropivacaina | Active comparator | Ropivacaine 2 % , dosage 10 ml frequency 1 one dosis duration 1 hour Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Measured: 10 minutes before epidural
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Measured: 5 minutes after epidural
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Measured: 10 minutes after epidural
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Measured: 15 minutes after epidural
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Measured: 30 minutes after epidural
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Measured: 45 minutes after epidural
Systemic vascular resistance ( units of measure :dyn*s/cm5)
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Measured: 60 minutes after epidural
Secondary outcomes (105)
Systolic Blood Pressure (units of measure :mmHg)
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Measured: 10 minutes before epidural
Systolic Blood Pressure (units of measure :mmHg)
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Measured: 5 minutes after epidural
Systolic Blood Pressure (units of measure :mmHg)
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Measured: 10 minutes after epidural
Systolic Blood Pressure (units of measure :mmHg)
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Measured: 15 minutes after epidural
Systolic Blood Pressure (units of measure :mmHg)
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Measured: 30 minutes after epidural
Systolic Blood Pressure (units of measure :mmHg)
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Measured: 45 minutes after epidural
Systolic Blood Pressure (units of measure :mmHg)
Systolic pressure refers to the pressure of blood in the artery when the heart contracts. It is the upper (and highest) number in a blood pressure measurement.
Measured: 60 minutes after epidural
Diastolic Blood Pressure (units of measure :mmHg)
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Measured: 10 minutes before epidural
Diastolic Blood Pressure (units of measure :mmHg)
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Measured: 5 minutes after epidural
Diastolic Blood Pressure (units of measure :mmHg)
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Measured: 10 minutes after epidural
Diastolic Blood Pressure (units of measure :mmHg)
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Measured: 15 minutes after epidural
Diastolic Blood Pressure (units of measure :mmHg)
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Measured: 30 minutes after epidural
Diastolic Blood Pressure (units of measure :mmHg)
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Measured: 45 minutes after epidural
Diastolic Blood Pressure (units of measure :mmHg)
Diastolic blood pressure refers to the pressure of blood in the artery when the heart relaxes between beats. It is the lower (and lower) number in a blood pressure measurement.
Measured: 60 minutes after epidural
Mean Arterial Pressure (units of measure :mmHg)
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is:
PAM = (GC x RVP) + PVC
Measured: 10 minutes before epidural
Mean Arterial Pressure (units of measure :mmHg)
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is:
PAM = (GC x RVP) + PVC
Measured: 5 minutes after epidural
Mean Arterial Pressure (units of measure :mmHg)
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is:
PAM = (GC x RVP) + PVC
Measured: 10 minutes after epidural
Mean Arterial Pressure (units of measure :mmHg)
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is:
PAM = (GC x RVP) + PVC
Measured: 15 minutes after epidural
Mean Arterial Pressure (units of measure :mmHg)
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is:
PAM = (GC x RVP) + PVC
Measured: 30 minutes after epidural
Mean Arterial Pressure (units of measure :mmHg)
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is:
PAM = (GC x RVP) + PVC
Measured: 45 minutes after epidural
Mean Arterial Pressure (units of measure :mmHg)
Mean arterial pressure (MAP) is determined by cardiac output (CO), peripheral vascular resistance (PVR), and central venous pressure (CVP). The formula that integrates these concepts is:
PAM = (GC x RVP) + PVC
Measured: 60 minutes after epidural
Pulse Pressure (units of measure :mmHg)
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Measured: 10 minutes before epidural
Pulse Pressure (units of measure :mmHg)
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Measured: 5 minutes after epidural
Pulse Pressure (units of measure :mmHg)
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Measured: 10 minutes after epidural
Pulse Pressure (units of measure :mmHg)
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Measured: 15 minutes after epidural
Pulse Pressure (units of measure :mmHg)
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Measured: 30 minutes after epidural
Pulse Pressure (units of measure :mmHg)
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Measured: 45 minutes after epidural
Pulse Pressure (units of measure :mmHg)
Pulse pressure is the difference between systolic blood pressure (SBP) and diastolic blood pressure (DBP), and is an index of arterial compliance.
Measured: 60 minutes after epidural
Cardiac Output (units of measure :L/min)
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume:
Cardiac output = heart rate x stroke volume
Measured: 10 minutes before epidural
Cardiac Output (units of measure :L/min)
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume:
Cardiac output = heart rate x stroke volume
Measured: 5 minutes after epidural
Cardiac Output (units of measure :L/min)
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume:
Cardiac output = heart rate x stroke volume
Measured: 10 minutes after epidural
Cardiac Output (units of measure :L/min)
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume:
Cardiac output = heart rate x stroke volume
Measured: 15 minutes after epidural
Cardiac Output (units of measure :L/min)
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume:
Cardiac output = heart rate x stroke volume
Measured: 30 minutes after epidural
Cardiac Output (units of measure :L/min)
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume:
Cardiac output = heart rate x stroke volume
Measured: 45 minutes after epidural
Cardiac Output (units of measure :L/min)
The volume of blood pumped from a ventricle each minute is known as cardiac output. It is the product of heart rate and stroke volume:
Cardiac output = heart rate x stroke volume
Measured: 60 minutes after epidural
Cardiac Index ( units of measure :L/min/m2)
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index.
Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate * Stroke Volume) / Body Surface Area
Measured: 10 minutes before epidural
Cardiac Index ( units of measure :L/min/m2)
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index.
Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate * Stroke Volume) / Body Surface Area
Measured: 5 minutes after epidural
Cardiac Index ( units of measure :L/min/m2)
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index.
Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate * Stroke Volume) / Body Surface Area
Measured: 10 minutes after epidural
Cardiac Index ( units of measure :L/min/m2)
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index.
Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate * Stroke Volume) / Body Surface Arealimits) will also be included
Measured: 15 minutes after epidural
Cardiac Index ( units of measure :L/min/m2)
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index.
Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate * Stroke Volume) / Body Surface Area
Measured: 30 minutes after epidural
Cardiac Index ( units of measure :L/min/m2)
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index.
Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate * Stroke Volume) / Body Surface Area
Measured: 45 minutes after epidural
Cardiac Index ( units of measure :L/min/m2)
A cardio dynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index.
Cardiac Index = Cardiac Output / Body Surface Area = (Heart Rate * Stroke Volume) / Body Surface Area
Measured: 60 minutes after epidural
Pulse Pressure Variation ( units of measure :% Percent)
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as [(PPmax - PPmin)/(PPmax
+ PPmin)/2] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Measured: 10 minutes before epidural
Pulse Pressure Variation ( units of measure :% Percent)
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as [(PPmax - PPmin)/(PPmax
+ PPmin)/2] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Measured: 5 minutes after epidural
Pulse Pressure Variation ( units of measure :% Percent)
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as [(PPmax - PPmin)/(PPmax
+ PPmin)/2] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Measured: 10 minutes after epidural
Pulse Pressure Variation ( units of measure :% Percent)
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as [(PPmax - PPmin)/(PPmax
+ PPmin)/2] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Measured: 15 minutes after epidural
Pulse Pressure Variation ( units of measure :% Percent)
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as [(PPmax - PPmin)/(PPmax
+ PPmin)/2] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Measured: 30 minutes after epidural
Pulse Pressure Variation ( units of measure :% Percent)
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as [(PPmax - PPmin)/(PPmax
+ PPmin)/2] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Measured: 45 minutes after epidural
Pulse Pressure Variation ( units of measure :% Percent)
Pulse pressure variation (PPV) is an effective and widely used dynamic parameter to predict the increase in cardiac output after fluid administration. Ideally, PPV measurement should be performed with a closed chest and mechanical ventilation with a tidal volume of 8 mL/kg.PPV was calculated as the percentage changes in arterial pulse pressure during a ventilatory cycle as [(PPmax - PPmin)/(PPmax
+ PPmin)/2] × 100, where PPmax and PPmin represent the maximal and minimal arterial pulse pressure, respectively
Measured: 60 minutes after epidural
(Maternal) Heart Rate (units of measure: beats per minute)
The number of times the heart beats during a certain period, usually one minute.
The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
Measured: 10 minutes before epidural
(Maternal) Heart Rate (units of measure: beats per minute)
The number of times the heart beats during a certain period, usually one minute.
The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
Measured: 5 minutes after epidural
(Maternal) Heart Rate (units of measure: beats per minute)
The number of times the heart beats during a certain period, usually one minute.
The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
Measured: 10 minutes after epidural
(Maternal) Heart Rate (units of measure: beats per minute)
The number of times the heart beats during a certain period, usually one minute.
The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
Measured: 15 minutes after epidural
(Maternal) Heart Rate (units of measure: beats per minute)
The number of times the heart beats during a certain period, usually one minute.
The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
Measured: 30 minutes after epidural
(Maternal) Heart Rate (units of measure: beats per minute)
The number of times the heart beats during a certain period, usually one minute.
The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
Measured: 45 minutes after epidural
(Maternal) Heart Rate (units of measure: beats per minute)
The number of times the heart beats during a certain period, usually one minute.
The resting heart rate normally ranges from 60 to 100 beats per minute in a healthy adult at rest.
Measured: 60 minutes after epidural
Stroke Volume (units of measure :ml)
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Measured: 10 minutes before epidural
Stroke Volume (units of measure :ml)
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Measured: 5 minutes after epidural
Stroke Volume (units of measure :ml)
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Measured: 10 minutes after epidural
Stroke Volume (units of measure :ml)
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Measured: 15 minutes after epidural
Stroke Volume (units of measure :ml)
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Measured: 30 minutes after epidural
Stroke Volume (units of measure :ml)
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Measured: 45 minutes after epidural
Stroke Volume (units of measure :ml)
Stroke volume is the volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction. The SV volume may be calculated as the difference between the left ventricular end-diastolic volume and the left ventricular end-systolic volume (ESV).
Measured: 60 minutes after epidural
Systolic Variation Volume ( units of measure :% Percent)
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Measured: 10 minutes before epidural
Systolic Variation Volume ( units of measure :% Percent)
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Measured: 5 minutes after epidural
Systolic Variation Volume ( units of measure :% Percent)
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Measured: 10 minutes after epidural
Systolic Variation Volume ( units of measure :% Percent)
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Measured: 15 minutes after epidural
Systolic Variation Volume ( units of measure :% Percent)
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Measured: 30 minutes after epidural
Systolic Variation Volume ( units of measure :% Percent)
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Measured: 45 minutes after epidural
Systolic Variation Volume ( units of measure :% Percent)
Stroke volume variation (SVV) has been shown to be a reliable predictor of fluid responsiveness.SVV is assessed using the following equation: SVV (%) = (SVmax - SVmin)/SVmean
Measured: 60 minutes after epidural
Arterial Oxigen Saturation ( units of measure :% Percent)
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Measured: 10 minutes before epidural
Arterial Oxigen Saturation ( units of measure :% Percent)
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Measured: 5 minutes after epidural
Arterial Oxigen Saturation ( units of measure :% Percent)
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Measured: 10 minutes after epidural
Arterial Oxigen Saturation ( units of measure :% Percent)
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Measured: 15 minutes after epidural
Arterial Oxigen Saturation ( units of measure :% Percent)
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Measured: 30 minutes after epidural
Arterial Oxigen Saturation ( units of measure :% Percent)
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Measured: 45 minutes after epidural
Arterial Oxigen Saturation ( units of measure :% Percent)
Arterial oxygen saturation (SaO2) is a measure of hemoglobin oxygenation in the arterial compartment of the circulatory system. It is not a measure of the total oxygen content in the arterial blood because a small fraction of oxygen (about 2%) is dissolved in the plasma. To determine overall oxygen-carrying capacity of the blood, multiply 1.34 ml/g by the patient's hemoglobin level in g/dL and by Spo2.
Measured: 60 minutes after epidural
Fetal heart rate (units of measure: beats per minute)
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Measured: 10 minutes before epidural
Fetal heart rate (units of measure: beats per minute)
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Measured: 5 minutes after epidural
Fetal heart rate (units of measure: beats per minute)
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Measured: 10 minutes after epidural
Fetal heart rate (units of measure: beats per minute)
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Measured: 15 minutes after epidural
Fetal heart rate (units of measure: beats per minute)
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Measured: 30 minutes after epidural
Fetal heart rate (units of measure: beats per minute)
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Measured: 45 minutes after epidural
Fetal heart rate (units of measure: beats per minute)
The average fetal heart rate is between 110 and 160 beats per minute. It can vary by 5 to 25 beats per minute. The fetal heart rate may change by differents conditions in the uterus. An abnormal fetal heart rate may mean that is not getting enough oxygen or that there are other problems.
Measured: 60 minutes after epidural
Variability (units of measure: beats per minute)
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Measured: 10 minutes before epidural
Variability (units of measure: beats per minute)
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Measured: 5 minutes after epidural
Variability (units of measure: beats per minute)
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Measured: 10 minutes after epidural
Variability (units of measure: beats per minute)
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Measured: 15 minutes after epidural
Variability (units of measure: beats per minute)
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Measured: 30 minutes after epidural
Variability (units of measure: beats per minute)
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Measured: 45 minutes after epidural
Variability (units of measure: beats per minute)
This the minor fluctuation in baseline FHR. It is assessed by estimating the difference in bpm between the highest peak and lowest trough of fluctuation in one minute segments of the trace
Measured: 60 minutes after epidural
Accelerations (units of measure: beats per minute)
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Measured: 10 minutes before epidural
Accelerations (units of measure: beats per minute)
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Measured: 5 minutes after epidural
Accelerations (units of measure: beats per minute)
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Measured: 10 minutes after epidural
Accelerations (units of measure: beats per minute)
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Measured: 15 minutes after epidural
Accelerations (units of measure: beats per minute)
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Measured: 30 minutes after epidural
Accelerations (units of measure: beats per minute)
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Measured: 45 minutes after epidural
Accelerations (units of measure: beats per minute)
These are transient increases in FHR of 15bpm or more above the baseline and lasting 15 seconds.
Measured: 60 minutes after epidural
Decelerations (units of measure: beats per minute)
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Measured: 10 minutes before epidural
Decelerations (units of measure: beats per minute)
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Measured: 5 minutes after epidural
Decelerations (units of measure: beats per minute)
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Measured: 10 minutes after epidural
Decelerations (units of measure: beats per minute)
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Measured: 15 minutes after epidural
Decelerations (units of measure: beats per minute)
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Measured: 30 minutes after epidural
Decelerations (units of measure: beats per minute)
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Measured: 45 minutes after epidural
Decelerations (units of measure: beats per minute)
These are transient episodes of decrease of FHR below the baseline of more than 15 bpm lasting at least 15 seconds.
Measured: 60 minutes after epidural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de Manresa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauricio Roberto Argañaraz Quinteros, Althaia Xarxa Assistencial Universitària de Manresa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877131
- Sponsor's protocol ID
- CEI-pendiente
- Status last verified
- May 2023
- First submitted
- 20 Mar 2023
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
ACOG Committee on Practice Bulletins. ACOG practice bulletin. Clinical management guidelines for obstetrician-gynecologists. Number 44, July 2003. (Replaces Committee Opinion Number 252, March 2001). Obstet Gynecol. 2003 Jul;102(1):203-13. No abstract available.
PubMed 12850637Preston R, Crosby ET, Kotarba D, Dudas H, Elliott RD. Maternal positioning affects fetal heart rate changes after epidural analgesia for labour. Can J Anaesth. 1993 Dec;40(12):1136-41. doi: 10.1007/BF03009602.
PubMed 8281589Lappen JR, Chien EK, Mercer BM. Contraction-Associated Maternal Heart Rate Decelerations: A Pragmatic Marker of Intrapartum Volume Status. Obstet Gynecol. 2018 Oct;132(4):1011-1017. doi: 10.1097/AOG.0000000000002808.
PubMed 30130346Valensise H, Lo Presti D, Tiralongo GM, Pisani I, Gagliardi G, Vasapollo B, Frigo MG. Foetal heart rate deceleration with combined spinal-epidural analgesia during labour: a maternal haemodynamic cardiac study. J Matern Fetal Neonatal Med. 2016;29(12):1980-6. doi: 10.3109/14767058.2015.1072156. Epub 2015 Aug 28.
PubMed 26333691Collins KM, Bevan DR, Beard RW. Fluid loading to reduce abnormalities of fetal heart rate and maternal hypotension during epidural analgesia in labour. Br Med J. 1978 Nov 25;2(6150):1460-1. doi: 10.1136/bmj.2.6150.1460.
PubMed 719463Umstad MP, Ross A, Rushford DD, Permezel M. Epidural analgesia and fetal heart rate abnormalities. Aust N Z J Obstet Gynaecol. 1993 Aug;33(3):269-72. doi: 10.1111/j.1479-828x.1993.tb02083.x.
PubMed 8304890Kubli M, Shennan AH, Seed PT, O'Sullivan G. A randomised controlled trial of fluid pre-loading before low dose epidural analgesia for labour. Int J Obstet Anesth. 2003 Oct;12(4):256-60. doi: 10.1016/S0959-289X(03)00071-2.
PubMed 15321453Hofmeyr G, Cyna A, Middleton P. Prophylactic intravenous preloading for regional analgesia in labour. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD000175. doi: 10.1002/14651858.CD000175.pub2.
PubMed 15494990Peyronnet V, Roses A, Girault A, Bonnet MP, Goffinet F, Tsatsaris V, Lecarpentier E. Lower limbs venous compression reduces the incidence of maternal hypotension following epidural analgesia during term labor. Eur J Obstet Gynecol Reprod Biol. 2017 Dec;219:94-99. doi: 10.1016/j.ejogrb.2017.10.016. Epub 2017 Oct 16.
PubMed 29073508
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate the Efficacy of Levobupivacaine 0.125% vs Ropivacaine 0.2%, in Hemodynamic Alterations in Pregnant Women in Labor and Their Fetal Repercussions
- ClinicalTrials.gov ID
- NCT05877131
- Acronym / sponsor ID
- CEI-pendiente
- Conditions
- Hemodynamic Instability, Epidural, Pregnancy, Fetal Cardiac Disorder
- Keywords
- Hemodynamic instability, Epidural, Pregnancy, Fetal Cardiac disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de ManresaUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
INTRODUCTION:
Most studies on analgesia in pregnant women in labor mainly evaluate the effect of anesthetics on pain, mentioning hypotension as a side effect without investigating its impact on fetal well-being. The objective of the present study is to evaluate the efficacy of the use of low doses of local anesthetic (LA) to prevent hemodynamic alterations that manifest as a loss of fetal well-being.
METHODOLOGY/DESIGN:
It is a randomized clinical trial. Patients will be pregnant women in labor (dilation period) who want epidural anesthesia (EA), who will randomly receive 0.125% levobupivacaine (Group L) versus 0.2% ropivacaine (Group R). In both groups, controls of hemodynamic parameters and their relationship with changes in fetal heart rate (FHR) and cardiotocographic recording (RCTG) will be carried out during the first 60 minutes after the administration of the local anesthetic via the epidural route. In case of hypotension and/or subsequent FHR and RCTG alterations, they will also be recorded. The follow-up period will extend from the moment the patient enters the delivery room and requests epidural anesthesia until the moment the patient is discharged from the delivery room. The percentage of patients with hemodynamic alterations will be evaluated as a primary result, as well as the percentage of patients whose hemodynamic alterations are related to changes in FHR and RCTG, when using low doses of LA. In the following will also be evaluated in relation to analgesia, the onset time, level reached and degree of satisfaction; and various intra and postpartum side effects.
DISCUSSION:
Both groups of pregnant women in labor will be studied in order to obtain data on the potential impact of the use of low doses of local anesthetic via the epidural route on hemodynamic parameters and the state of well-being of the fetus.
Detailed description
Any patient presenting in the delivery room or gynecology-obstetrics office of the hospital with prodromes, midwives or gynecologists will inform the principal investigator (PI). The IP will contact the patient to inform them of what the study consists of and if they wish to participate in it. In case of acceptance, the explanatory documentation and a questionnaire will be delivered to determine if it meets the inclusion criteria. If the pregnant patient at term meets the inclusion criteria, she is recruited to enter the study, it will also be used to resolve any doubts that the patient may have. Once the patient has signed the informed consent, the collaborating researcher (CI) of the recruiting center will be notified to contact the Althaia Innovation and Research Unit to find out the patient's assignment group. The collaborating researcher will be in charge of notifying the patient of the group to which she has been assigned (Intervention Group A or B).
Initially, the basal hemodynamic constants will be recorded: systolic blood pressure (SBP), mean blood pressure (TAM), diastolic blood pressure (TAD), pulse pressure (PP), systemic vascular resistance (SVR), cardiac output (CO), index Pulse Pressure Variation (PPV), Stroke Volume Variation (SVV), Heart Rate (HR), Stroke Volume (SV), Partial Pressure Oxygen Saturation (SpO2) via Clearsight device ®; pain score (VAS); degree of anxiety/depression by filling in a questionnaire to complete yourself; the degree of dilation. The FHR will also be recorded, as well as the different pathological patterns of the RCTG that appear, the Philips Avalon FM 30 monitor will be used for this.
The steps to follow for the administration of local anesthetic through the epidural catheter will be the following:
The mother's data (before and after AE) will be collected, including hemodynamic data: systolic blood pressure (SBP), mean blood pressure (TAM), diastolic blood pressure (TAD), pulse pressure (PP), vascular resistance heart rate (SVR), cardiac output (CO), cardiac index (CI), pulse pressure variation (PPV), stroke volume variation (VSV), heart rate (HR), stroke volume (SV), blood saturation partial pressure of oxygen (SpO2); pain score (VAS), degree of analgesia achieved, satisfaction obtained, time onset of analgesia, level of sensory block using the pin-prick test and the hot-cold test; degree of anxiety/depression by filling in a questionnaire to complete yourself; the degree of dilation. The fetal data (before and after the AE) of the FHR (values above or below the normal limits) will also be included, as well as the different pathological patterns of the RCTG that appear, due to hypotension or alterations. associated hemodynamics.
All pregnant women who will participate in this study will carry an intravenous cannula and will receive a fluid load of 500 cc. The position of the patients will be in a sitting position and the epidural puncture will be performed at the level of the L2-3 or L3-4 intervertebral space using a Tuohy 18 epidural needle. The loss of resistance technique with air or saline will be used according to the standards of our service.
A volume of 2 ml of 2% lidocaine will be administered via the epidural via the epidural catheter, after 3 minutes (it will be evaluated if undesirable effects appear: such as motor block due to accidental dural puncture, hypotension, nausea, vomiting), it will be administered to pregnant women the final volume (10 cc) of the local anesthetic randomly assigned via epidural.
After the administration of the initial bolus (Group A - Group B), the different constants or parameters to be evaluated will be recorded.
The measurement of the different hemodynamic variables will be recorded through a non-invasive device, the Clearsight®. The device will automatically determine the constants, which will be recorded at 5, 10, 15, 30, 45 and 60 minutes.
In the event of recording an episode of hypotension after the first 60 minutes, a record of all the hemodynamic variables evaluated will be made every 5 minutes for the following 60 minutes.
It will be determined which of the local anesthetics at low concentrations administered via the epidural is related to alteration of the hemodynamic parameters. To measure the different parameters, a non-invasive device (Clearsight) will be used, which will determine the existing hemodynamic alterations before, after, and during the first hour after the administration of the initial dose through the lumbar epidural catheter, as well as in the event of an episode. of hypotension or changes in FHR and/or RCTG after the first hour of catheter placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levobupivacaina | Active comparator | Drug: LevobupivacaineLevobupivacaine 0.125% , dosage 10 ml frequency 1 one dosis duration 1 hour |
| Ropivacaina | Active comparator | Drug: RopivacaineRopivacaine 2 % , dosage 10 ml frequency 1 one dosis duration 1 hour |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- - Woman > 18 years
- Request epidural anesthesia (EA)
- Expansion period
- Low obstetric risk
- ASA I-II (only one associated comorbidity, example: arterial hypertension, etc.)
Key exclusion criteria (12 listed)
- VAS ≤ 2
- Breech presentation
- Maternal fever > 38 years
- Pre-eclampsia and severe eclampsia
- Prenatal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevobupivacaineTo evaluate the efficacy of low-dose levobupivacaine (0.125%) (0.2) in avoiding hemodynamic changes after performing regional analgesia in pregnant women in labor and preventing changes in fetal heart rate and cardiotocographic recording. | Drug | Levobupivacaina |
| RopivacaineTo evaluate the efficacy of low-dose ropivacaine (0.2) in avoiding hemodynamic changes after performing regional analgesia in pregnant women in labor and preventing changes in fetal heart rate and cardiotocographic recording. | Drug | Ropivacaina |
Primary outcome
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Time frame: 10 minutes before epidural
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Time frame: 5 minutes after epidural
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Time frame: 10 minutes after epidural
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Time frame: 15 minutes after epidural
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Time frame: 30 minutes after epidural
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Systemic vascular resistance ( units of measure:dyn*s/cm5)
Time frame: 45 minutes after epidural
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
Systemic vascular resistance ( units of measure :dyn*s/cm5)
Time frame: 60 minutes after epidural
Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.
105 secondary outcomes
Systolic Blood Pressure (units of measure :mmHg)
Time frame: 10 minutes before epidural
Systolic Blood Pressure (units of measure :mmHg)
Time frame: 5 minutes after epidural
Systolic Blood Pressure (units of measure :mmHg)
Time frame: 10 minutes after epidural
Systolic Blood Pressure (units of measure :mmHg)
Time frame: 15 minutes after epidural
Systolic Blood Pressure (units of measure :mmHg)
Time frame: 30 minutes after epidural
Systolic Blood Pressure (units of measure :mmHg)
Time frame: 45 minutes after epidural
Systolic Blood Pressure (units of measure :mmHg)
Time frame: 60 minutes after epidural
Diastolic Blood Pressure (units of measure :mmHg)
Time frame: 10 minutes before epidural
Diastolic Blood Pressure (units of measure :mmHg)
Time frame: 5 minutes after epidural
Diastolic Blood Pressure (units of measure :mmHg)
Time frame: 10 minutes after epidural
Diastolic Blood Pressure (units of measure :mmHg)
Time frame: 15 minutes after epidural
Diastolic Blood Pressure (units of measure :mmHg)
Time frame: 30 minutes after epidural
Diastolic Blood Pressure (units of measure :mmHg)
Time frame: 45 minutes after epidural
Diastolic Blood Pressure (units of measure :mmHg)
Time frame: 60 minutes after epidural
Mean Arterial Pressure (units of measure :mmHg)
Time frame: 10 minutes before epidural
Mean Arterial Pressure (units of measure :mmHg)
Time frame: 5 minutes after epidural
Mean Arterial Pressure (units of measure :mmHg)
Time frame: 10 minutes after epidural
Mean Arterial Pressure (units of measure :mmHg)
Time frame: 15 minutes after epidural
Mean Arterial Pressure (units of measure :mmHg)
Time frame: 30 minutes after epidural
Mean Arterial Pressure (units of measure :mmHg)
Time frame: 45 minutes after epidural
Mean Arterial Pressure (units of measure :mmHg)
Time frame: 60 minutes after epidural
Pulse Pressure (units of measure :mmHg)
Time frame: 10 minutes before epidural
Pulse Pressure (units of measure :mmHg)
Time frame: 5 minutes after epidural
Pulse Pressure (units of measure :mmHg)
Time frame: 10 minutes after epidural
Pulse Pressure (units of measure :mmHg)
Time frame: 15 minutes after epidural
Pulse Pressure (units of measure :mmHg)
Time frame: 30 minutes after epidural
Pulse Pressure (units of measure :mmHg)
Time frame: 45 minutes after epidural
Pulse Pressure (units of measure :mmHg)
Time frame: 60 minutes after epidural
Cardiac Output (units of measure :L/min)
Time frame: 10 minutes before epidural
Cardiac Output (units of measure :L/min)
Time frame: 5 minutes after epidural
Cardiac Output (units of measure :L/min)
Time frame: 10 minutes after epidural
Cardiac Output (units of measure :L/min)
Time frame: 15 minutes after epidural
Cardiac Output (units of measure :L/min)
Time frame: 30 minutes after epidural
Cardiac Output (units of measure :L/min)
Time frame: 45 minutes after epidural
Cardiac Output (units of measure :L/min)
Time frame: 60 minutes after epidural
Cardiac Index ( units of measure :L/min/m2)
Time frame: 10 minutes before epidural
Cardiac Index ( units of measure :L/min/m2)
Time frame: 5 minutes after epidural
Cardiac Index ( units of measure :L/min/m2)
Time frame: 10 minutes after epidural
Cardiac Index ( units of measure :L/min/m2)
Time frame: 15 minutes after epidural
Cardiac Index ( units of measure :L/min/m2)
Time frame: 30 minutes after epidural
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Background: PubMed 12850637ACOG Committee on Practice Bulletins. ACOG practice bulletin. Clinical management guidelines for obstetrician-gynecologists. Number 44, July 2003. (Replaces Committee Opinion Number 252, March 2001). Obstet Gynecol. 2003 Jul;102(1):203-13. No abstract available.
- Background: PubMed 8281589Preston R, Crosby ET, Kotarba D, Dudas H, Elliott RD. Maternal positioning affects fetal heart rate changes after epidural analgesia for labour. Can J Anaesth. 1993 Dec;40(12):1136-41. doi: 10.1007/BF03009602.
- Background: PubMed 30130346Lappen JR, Chien EK, Mercer BM. Contraction-Associated Maternal Heart Rate Decelerations: A Pragmatic Marker of Intrapartum Volume Status. Obstet Gynecol. 2018 Oct;132(4):1011-1017. doi: 10.1097/AOG.0000000000002808.
- Background: PubMed 26333691Valensise H, Lo Presti D, Tiralongo GM, Pisani I, Gagliardi G, Vasapollo B, Frigo MG. Foetal heart rate deceleration with combined spinal-epidural analgesia during labour: a maternal haemodynamic cardiac study. J Matern Fetal Neonatal Med. 2016;29(12):1980-6. doi: 10.3109/14767058.2015.1072156. Epub 2015 Aug 28.
- Background: PubMed 719463Collins KM, Bevan DR, Beard RW. Fluid loading to reduce abnormalities of fetal heart rate and maternal hypotension during epidural analgesia in labour. Br Med J. 1978 Nov 25;2(6150):1460-1. doi: 10.1136/bmj.2.6150.1460.
- Background: PubMed 8304890Umstad MP, Ross A, Rushford DD, Permezel M. Epidural analgesia and fetal heart rate abnormalities. Aust N Z J Obstet Gynaecol. 1993 Aug;33(3):269-72. doi: 10.1111/j.1479-828x.1993.tb02083.x.
- Background: PubMed 15321453Kubli M, Shennan AH, Seed PT, O'Sullivan G. A randomised controlled trial of fluid pre-loading before low dose epidural analgesia for labour. Int J Obstet Anesth. 2003 Oct;12(4):256-60. doi: 10.1016/S0959-289X(03)00071-2.
- Background: PubMed 15494990Hofmeyr G, Cyna A, Middleton P. Prophylactic intravenous preloading for regional analgesia in labour. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD000175. doi: 10.1002/14651858.CD000175.pub2.
- Background: PubMed 29073508Peyronnet V, Roses A, Girault A, Bonnet MP, Goffinet F, Tsatsaris V, Lecarpentier E. Lower limbs venous compression reduces the incidence of maternal hypotension following epidural analgesia during term labor. Eur J Obstet Gynecol Reprod Biol. 2017 Dec;219:94-99. doi: 10.1016/j.ejogrb.2017.10.016. Epub 2017 Oct 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susana Gonzalez Suarez contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levobupivacaine and Ropivacaine in people with Hemodynamic Instability and Epidural, run by Althaia Xarxa Assistencial Universitària de Manresa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mauricio Roberto Argañaraz Quinteros, Physician (0034600609107, mraq1969@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic vascular resistance ( units of measure:dyn*s/cm5) (time frame: 10 minutes before epidural). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05877131, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.