Hip FracturesPhase 4NCT03843970
Hemodynamic Safety of Levobupivacaine vs Bupivacaine in Patients Over 65 Years Undergoing Hip Surgery
A Phase 4 study testing Levobupivacaine Hydrochloride 0.5% and Isobaric bupivacaine 0.5% in people with Hip Fractures and Hemodynamic Stability, run by Hospital Clínico Universitario de Valencia at 1 site in Spain.
Trial summary
The altered hemodynamics, and therefore the arterial hypotension is the most prevalent adverse effect after subarachnoid anesthesia. The objective of the study was to determine the exact role of local anesthetic selection underlying spinal anesthesia-induced hypotension in the elderly patient. Read more about this study
- Who is it for?
- Ages 65 to 120 years
- Conditions the study is for
- Hip Fractures, Hemodynamic Stability
- What is being tested?
- Levobupivacaine Hydrochloride 0.5% and Isobaric bupivacaine 0.5%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 14 Jun 2018to 31 Jul 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 65 to 120 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Men and Women over 65 years
- Who meet the requirements in the pre-anesthetic to be treated with spinal anesthesia with levobupivacaine or bupivacaine, both with fentanyl,
- Fitness: from I to IV, according to the American Society of Anesthesiologists (ASA),
- Weight> 40 kg,
- Height> 140 cm,
- Body mass index (BMI) <50 kg/m2,
- Pathology cardiovascular, respiratory, renal and endocrine-metabolic,
- Provide written informed consent
Who cannot join
- Patients with uncontrolled hypertension (non-invasive systolic blood pressure> 180 mmHg and / or non-invasive diastolic blood pressure > 110mmHg),
- HR> 120 bpm,
- SpO2 <90% on arrival in the operating room and the contraindication to perform neuraxial anesthesia (patient refusal, infection at the site of puncture or lancing different, neuromuscular degenerative disease, hypovolemia, coagulopathy or anticoagulant therapy, morbid obesity, and extreme increase in intracranial pressure).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Universitario
Valencia, 46010
HERRERA ROSA, PhD, +34961.973.500, 35606rhc@gmail.com
TORNERO CARLOS, PhD, +34961.973.500, carlos.tornero@uv.es
About this study
Official title: Hemodynamic Safety of Isobaric Levobupivacaine Versus Isobaric Bupivacaine for Subarachnoid Anesthesia in Patients Over 65 Years Undergoing Hip Surgery
The altered hemodynamics, and therefore the arterial hypotension is the most prevalent adverse effect after subarachnoid anesthesia. The objective of the study was to determine the exact role of local anesthetic selection underlying spinal anesthesia-induced hypotension in the elderly patient. We conducted a descriptive, interventional pilot study to assess the hemodynamic impact of subarachnoid anesthesia with isobaric levobupivacaine versus isobaric bupivacaine for hip fracture surgery.
Read the detailed description
- Objective of the trial 1.1. Main objective: Compare the hemodynamic effects from invasive systolic diastolic and mean blood pressures (ISBP, IDBP and IMBP) mesured in mmHg, arterial partial pressure of oxygen (PaO2) and arterial partial pressure of carbon dioxide (PaCO2) measured in mmHg , arterial oxygen saturation (SatO2) measured in%, heart rate (HR / bpm) measured in beats per minute. Other variables of interest will be: cardiac index (CI) mesured in litres per minute per square metre (L/min/m2), peripheral vascular resistance (PVR) medured in dynes/seconds/cm-5, partial arterial pressure of oxygen (PaO2) and arterial partial pressure of carbon dioxide (PaCO2) measured in mmHg, pH (pH), arterial lactate (Lc) measured in mmol / L, arterial hemoglobin (Hb) measured in g/dl, partial oxygen saturation (SpO2%) measured in %. 1.2. Secondary objectives: Assess potential adverse events during surgery and 48 hours of surgery. Adverse events include adverse cardiovascular and respiratory rate, events related to both surgical and anesthetic techniques and exitus.
- End points 2.1. Primary end point(s): hemodynamic variables invasive systolic blood pressure (ISBP) measured in mmHg invasive diastolic blood pressure (ISBP), measured in mmHg invasive mean blood pressure (IMBP), measured in mmHg arterial partial pressure of oxygen (PaO2) arterial partial pressure of carbon dioxide (PaCO2), measured in mmHg arterial oxygen saturation (SatO2) measured in% heart rate (HR / bpm) measured in beats per minute cardiac index (CI) mesured in litres per minute per square metre (L/min/m2). peripheral vascular resistance (PVR) mesured in dynes/seconds/cm-5 partial arterial pressure of oxygen (PaO2) measured in mmHg arterial partial pressure of carbon dioxide (PaCO2) measured in mmHg pH (pH) arterial lactate (Lc) measured in mmol / L arterial hemoglobin (Hb) measured in g / dl partial oxygen saturation (SpO2%) measured in %.
2.1.1 Timepoint(s) of evaluation of this end point: entry into the operating room, after 30 minutes of anesthesia and at the end of anesthesia.
2.2. Secondary end point(s):
- Intraoperative adverse events:
- Cardiovascular and Respiratory: Venous air embolism (VAE), deep vein thrombosis (DVT), myocardial infarction (AMI), cerebrovascular accident (CVA), congestive heart failure (CHF), pneumonia (N), Exitus (Ex)
- Other: Acute renal failure (ARF), vomiting (V)
- Associated with the surgical technique: RBC transfusion (Th), plasma transfusion (TPL), nerve damage (ln), femur fracture (Fx f)
- Associated with the anesthetic technique: paresthesia (pair), hematic puncture (ph), other.
B.Postoperative adverse events (at 48 hours)
- Cardiovascular and Respiratory: Deep vein thrombosis (DVT), myocardial infarction (AMI), cerebrovascular accident (CVA), congestive heart failure (CHF), pneumonia (N), Exitus (Ex)
- Other: Acute renal failure (ARF), UTI (Infu), vomiting (V).
- Associated with the surgical technique: RBC transfusion (Th), plasma transfusion (TPL), neurologic deficit (defnq), surgical wound infection (Infhq).
- Associated with the anesthetic technique: neurological deficit (defn), postdural puncture headache (PDPH), back pain (Lumb).
2.2.1. Timepoint(s) of evaluation of this end point: 48 hours of surgery
- Conditions
- Hip Fractures, Hemodynamic Stability
- Being tested
- Levobupivacaine Hydrochloride 0.5%, Isobaric bupivacaine 0.5%
- Keywords
- Hip fracture, Subarachnoid block
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levobupivacaine Hydrochloride 0.5%Drug
Also called L solution
The solution is called L solution, which contains a combination of 0.5% isobaric levobupivacaine with fentanyl. Injectable Solution.
Isobaric bupivacaine 0.5%Drug
Also called B solution
The solution is called B solution, which contains a combination of 0.5% isobaric bupivacaine with fentanyl. Injectable Solution.
| Study group | Role | What they receive |
|---|---|---|
| Levobupivacaine Hydrochloride 0,5% | Experimental | The doses used of Levobupivacaine Hydrochloride 0.5% will be 6 mg and the dose of fentanyl 10 μg. Receives: Drug: Levobupivacaine Hydrochloride 0.5% |
| isobaric bupivacaine 0,5% | Active comparator | The doses used of isobaric bupivacaine will be 6 mg and the dose of fentanyl 10 μg. Receives: Drug: Isobaric bupivacaine 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare hemodynamic effects from invasive systolic pressure, invasive diastolic pressure and mean blood pressure.
The measurement of invasive systolic pressure and invasive diastolic pressure and mean blood pressure mesured in mmHg.
Measured: Intraoperative
Compare hemodynamic effects from heart rate.
The measurement of heart rate in beats per minute.
Measured: Intraoperative
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Adverse events include adverse cardiovascular and respiratory rate, events related to both surgical and anesthetic techniques.
Measured: 48 hours of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start14 Jun 2018
- Primary completion31 May 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies 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
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clínico Universitario de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROSA HERRERA, MD, Hospital Clínico Universitario de Valencia
- Investigators
- HERRERA ROSA, PhD, Principal investigator, General University Hospital of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843970
- Sponsor's protocol ID
- CoLeBu
- Status last verified
- Mar 2022
- First submitted
- 28 May 2018
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Safety of Isobaric Levobupivacaine Versus Isobaric Bupivacaine for Subarachnoid Anesthesia in Patients Over 65 Years Undergoing Hip Surgery
- ClinicalTrials.gov ID
- NCT03843970
- Acronym / sponsor ID
- CoLeBu
- Conditions
- Hip Fractures, Hemodynamic Stability
- Keywords
- Hip fracture, Subarachnoid block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital Clínico Universitario de ValenciaUniversity, hospital or other
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 18 Feb 2019 (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.
The altered hemodynamics, and therefore the arterial hypotension is the most prevalent adverse effect after subarachnoid anesthesia. The objective of the study was to determine the exact role of local anesthetic selection underlying spinal anesthesia-induced hypotension in the elderly patient. We conducted a descriptive, interventional pilot study to assess the hemodynamic impact of subarachnoid anesthesia with isobaric levobupivacaine versus isobaric bupivacaine for hip fracture surgery.
Detailed description
- Objective of the trial 1.1. Main objective: Compare the hemodynamic effects from invasive systolic diastolic and mean blood pressures (ISBP, IDBP and IMBP) mesured in mmHg, arterial partial pressure of oxygen (PaO2) and arterial partial pressure of carbon dioxide (PaCO2) measured in mmHg , arterial oxygen saturation (SatO2) measured in%, heart rate (HR / bpm) measured in beats per minute. Other variables of interest will be: cardiac index (CI) mesured in litres per minute per square metre (L/min/m2), peripheral vascular resistance (PVR) medured in dynes/seconds/cm-5, partial arterial pressure of oxygen (PaO2) and arterial partial pressure of carbon dioxide (PaCO2) measured in mmHg, pH (pH), arterial lactate (Lc) measured in mmol / L, arterial hemoglobin (Hb) measured in g/dl, partial oxygen saturation (SpO2%) measured in %. 1.2. Secondary objectives: Assess potential adverse events during surgery and 48 hours of surgery. Adverse events include adverse cardiovascular and respiratory rate, events related to both surgical and anesthetic techniques and exitus.
- End points 2.1. Primary end point(s): hemodynamic variables invasive systolic blood pressure (ISBP) measured in mmHg invasive diastolic blood pressure (ISBP), measured in mmHg invasive mean blood pressure (IMBP), measured in mmHg arterial partial pressure of oxygen (PaO2) arterial partial pressure of carbon dioxide (PaCO2), measured in mmHg arterial oxygen saturation (SatO2) measured in% heart rate (HR / bpm) measured in beats per minute cardiac index (CI) mesured in litres per minute per square metre (L/min/m2). peripheral vascular resistance (PVR) mesured in dynes/seconds/cm-5 partial arterial pressure of oxygen (PaO2) measured in mmHg arterial partial pressure of carbon dioxide (PaCO2) measured in mmHg pH (pH) arterial lactate (Lc) measured in mmol / L arterial hemoglobin (Hb) measured in g / dl partial oxygen saturation (SpO2%) measured in %.
2.1.1 Timepoint(s) of evaluation of this end point: entry into the operating room, after 30 minutes of anesthesia and at the end of anesthesia.
2.2. Secondary end point(s):
- Intraoperative adverse events:
- Cardiovascular and Respiratory: Venous air embolism (VAE), deep vein thrombosis (DVT), myocardial infarction (AMI), cerebrovascular accident (CVA), congestive heart failure (CHF), pneumonia (N), Exitus (Ex)
- Other: Acute renal failure (ARF), vomiting (V)
- Associated with the surgical technique: RBC transfusion (Th), plasma transfusion (TPL), nerve damage (ln), femur fracture (Fx f)
- Associated with the anesthetic technique: paresthesia (pair), hematic puncture (ph), other.
B.Postoperative adverse events (at 48 hours)
- Cardiovascular and Respiratory: Deep vein thrombosis (DVT), myocardial infarction (AMI), cerebrovascular accident (CVA), congestive heart failure (CHF), pneumonia (N), Exitus (Ex)
- Other: Acute renal failure (ARF), UTI (Infu), vomiting (V).
- Associated with the surgical technique: RBC transfusion (Th), plasma transfusion (TPL), neurologic deficit (defnq), surgical wound infection (Infhq).
- Associated with the anesthetic technique: neurological deficit (defn), postdural puncture headache (PDPH), back pain (Lumb).
2.2.1. Timepoint(s) of evaluation of this end point: 48 hours of surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levobupivacaine Hydrochloride 0,5% | Experimental | Drug: Levobupivacaine Hydrochloride 0.5%The doses used of Levobupivacaine Hydrochloride 0.5% will be 6 mg and the dose of fentanyl 10 μg. |
| isobaric bupivacaine 0,5% | Active comparator | Drug: Isobaric bupivacaine 0.5%The doses used of isobaric bupivacaine will be 6 mg and the dose of fentanyl 10 μg. |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Men and Women over 65 years
- Who meet the requirements in the pre-anesthetic to be treated with spinal anesthesia with levobupivacaine or bupivacaine, both with fentanyl,
- Fitness: from I to IV, according to the American Society of Anesthesiologists (ASA),
- Weight> 40 kg,
- Height> 140 cm,
Key exclusion criteria (3 listed)
- Patients with uncontrolled hypertension (non-invasive systolic blood pressure> 180 mmHg and / or non-invasive diastolic blood pressure > 110mmHg),
- HR> 120 bpm,
- SpO2 <90% on arrival in the operating room and the contraindication to perform neuraxial anesthesia (patient refusal, infection at the site of puncture or lancing different, neuromuscular degenerative disease, hypovolemia, coagulopathy or anticoagulant therapy, morbid obesity, and extreme increase in intracranial pressure).
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 |
|---|---|---|
| Levobupivacaine Hydrochloride 0.5%Also: L solutionThe solution is called L solution, which contains a combination of 0.5% isobaric levobupivacaine with fentanyl. Injectable Solution. | Drug | Levobupivacaine Hydrochloride 0,5% |
| Isobaric bupivacaine 0.5%Also: B solutionThe solution is called B solution, which contains a combination of 0.5% isobaric bupivacaine with fentanyl. Injectable Solution. | Drug | isobaric bupivacaine 0,5% |
Primary outcome
Compare hemodynamic effects from invasive systolic pressure, invasive diastolic pressure and mean blood pressure.
Time frame: Intraoperative
The measurement of invasive systolic pressure and invasive diastolic pressure and mean blood pressure mesured in mmHg.
Compare hemodynamic effects from heart rate.
Time frame: Intraoperative
The measurement of heart rate in beats per minute.
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 48 hours of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- 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.
HERRERA ROSA, PhD principal investigator
General University Hospital of Valencia
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 Hydrochloride 0.5% and Isobaric bupivacaine 0.5% in people with Hip Fractures and Hemodynamic Stability, run by Hospital Clínico Universitario de Valencia 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 8 inclusion and 3 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 31 Mar 2022. 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 HERRERA Rosa, PhD (+34 659205338, 35606rhc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare hemodynamic effects from invasive systolic pressure, invasive diastolic pressure and mean blood pressure. (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2022.