Labor PainNCT06099938
Effect of Different Labour Analgesics on Maternal and Fetal Blood Flow Observed by Doppler Ultrasonography
An observational study of Labor Pain and Analgesia, run by First Affiliated Hospital of Jinan University at 1 site in China.
Trial summary
Background: The purpose of this study was to see how intrathecal injections of sufentanil, ropivacaine, and sufentanil added to ropivacaine affected blood flow in the uterine artery, umbilical artery, and middle cerebral artery for combined spinal and epidural labor analgesia using color doppler ultrasound (CDUs). Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Analgesia, Fetus Disorder
- What is being tested?
- sufentanil, ropivacaine
- Type of treatment
- Injection or infusion
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 1 Jan 2022
- Phase
- Observational
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: ASA grade I to II, aged 20 to 35 years, weighing 50 to 100 kg, 150-175 cm in height, and 37 to 41 weeks of gestation
Who may be able to join
- ASA grade I to II
- Aged 20 to 35 years
- Weighing 50 to 100 kg
- 150-175 cm in height
- 37 to 41 weeks of gestation
Who cannot join
- Women with contraindications of spinal anesthesia
- Maternal complications (such as pregnancy-induced hypertension, preeclampsia, cardiovascular and cerebrovascular diseases, etc.)
- Abnormal uterine contractions
- Abnormal placental function or position
- Signs of fetal distress
- Known fetal malformations
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510000
About this study
Official title: Effect of Different Labour Analgesics on Maternal UtA, Fetal UA and MCA Blood Flow Index Observed by Doppler Ultrasonography：a Prospective Randomized Double-blinded Controlled Trial
Background: The purpose of this study was to see how intrathecal injections of sufentanil, ropivacaine, and sufentanil added to ropivacaine affected blood flow in the uterine artery, umbilical artery, and middle cerebral artery for combined spinal and epidural labor analgesia using color doppler ultrasound (CDUs).
Methods: A total of 90 singleton full-term parturients who were evaluated by obstetricians for feasible vaginal delivery were collected prospectively and divided into three groups based on the randomization and double-blind principle: sufentanil (S), ropivacaine (R) group, each with 30 cases. Main indicators include color doppler blood flow resistance indices (S/D) of the uterine artery (UtA), umbilical artery (UA), and middle cerebral artery (MCA) before (T0) and 30 minutes (T1), 60 minutes (T2), 90minutes (T3) after analgesia. Fetal heart rate (FHR), maternal mean arterial pressure (MAP) at T0, T1, T2 and T3。
Read the detailed description
- Randomization and blinding Parturients in the study were randomly assigned to Sufentanil group (S) and Ropivacaine group (R) by non-blind personnel according to the computer random number table, and the allocation was hidden. The solution was prepared by an unblinded anesthesiologist and packaged in a blind way and administered by another anesthesiologist. The patients, anesthesia providers, data recorders, ultrasound examiners, obstetrical staff, and nursing staff remained blinded to group assignment throughout the study.
- Study intervention At the time of request for labor analgesia, patients were randomized to receive either sufentanil 5 μg (Group S) and ropivacaine 3mg (Group R) into the subarachnoid space. All groups received the standard epidural solution that contained 0.1% ropivacaine with 0.25 μg/ml sufentanil. Routine obstetric and anaesthetic monitoring was given after maternal entered the delivery room. An experienced the anesthesiologist select L3-4 lumbar vertebra clearance to puncture with standard sterile technique using loss of resistance when the puerpera palace has expanded to about 3 cm. After the puncture reached the epidural space, a 25-gauge lumbar anesthesia needle was used to puncture into the subarachnoid space. 2 mL of anesthetic drug as determined by her group randomization were administered into the cavity through the lumbar anesthesia needle after cerebrospinal fluid flow out. A 19-gauge spring-wound catheter was threaded 4-6 cm into the epidural space. All patients received a test dose of 3 ml of 1.5% lidocaine followed by an initial loading dose of 5 ml of the standard epidural solution. Epidural catheters into vessels or subarachnoid space were excluded. An analgesic pump (PCEA pump, 100ml) containing standard epidural solution was then connected to the epidural catheter at a background continuous infusion rate of 5 mL/h. The visual analogue score for pain (VAS) was performed 15 minutes after the injection dose, and if the VAS score fell below 3, the case was included in the study. An anesthesia provider assessed the adequacy of analgesia for the patients throughout the duration of labor. Any breakthrough pain was managed with a physician-administered epidural bolus. All obstetric analgesia procedures were performed by the same anesthesiologist to reduce errors due to technical reasons.
- Ultrasonic examination method The patients were placed in a supine position with calm breathing to perform doppler ultrasonography during the interval of contractions. Ultrasound probe was placed on fetal head area. Middle cerebral arteries (MCA) run anteriorly on both sides of the ring of cerebral arteries at the position of the double head diameter (see Figure 1A). We can get waveforms of MCA examined by pulsed wave doppler (see Figure 1B). The probe was placed at the placenta area, and we can see the fetal umbilical cord connecting to the center of the placenta. Umbilical artery (UA) could be identified by color flow, and its waveforms were examined by pulsed wave doppler (see Figure 1C and 1D). The probe was placed at the midpoint of the groin. The right and left uterine arteries (UtA) could be identified by color flow at the apparent crossover with the external iliac arteries, and pulsed wave doppler was used to obtain waveforms (see Figure 1E and 1F). 3 to 10 arterial spectrograms with clear edges and no background noise at baseline were selected. The above arterial blood flow indexes were measured three times and the average value was taken. The S/Dvalue of MCA、UA、UtA can be measured automatically by ultrasound instrument. All doppler examinations were performed by the same sonographer.
- Conditions
- Labor Pain, Analgesia, Fetus Disorder
- Being tested
- sufentanil, ropivacaine
- Keywords
- Sufentanil, Ropivacaine, Labor analgesia, Color Doppler ultrasound, Middle cerebral artery, Uterine artery, Umbilical artery
- Medical subject headings
- Labor Pain, Agnosia, Fetal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sufentanil, ropivacaineDrug
Also called Color Doppler ultrasound
The study used conventional anesthetic drugs to compare the effects of the two drugs on maternal and infant blood flow
| Study group | Role | What they receive |
|---|---|---|
| Group S | intrathecal injections of sufentanil Receives: Drug: sufentanil, ropivacaine | |
| Group R | intrathecal injections of ropivacaine Receives: Drug: sufentanil, ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
color doppler blood flow resistance indices (S/D）
S/D is an abbreviation for systolic/diastolic blood pressure.The patients were placed in a supine position with calm breathing to perform Doppler ultrasonography during the interval of contractions.
Measured: S/D measured before analgesia and 30 minutes, 60 minutes, 90minutes after analgesia
Secondary outcomes (2)
FHR
Fetal heart rate
Measured: Fetal heart rate measured before analgesia and 30 minutes, 60 minutes, 90minutes after analgesia
MAP
Mean arterial pressure
Measured: Mean arterial pressure before analgesia and 30 minutes, 60 minutes, 90minutes after analgesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Mar 2021
- Primary completion1 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Jinan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuqiong Liu, First Affiliated Hospital of Jinan University
- Investigators
- Xuemei Peng, Ph.d, Principal investigator, First Affiliated Hospital of Jinan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099938
- Sponsor's protocol ID
- june617
- Status last verified
- Oct 2023
- First submitted
- 14 Jun 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Labour Analgesics on Maternal UtA, Fetal UA and MCA Blood Flow Index Observed by Doppler Ultrasonography：a Prospective Randomized Double-blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT06099938
- Acronym / sponsor ID
- june617
- Conditions
- Labor Pain, Analgesia, Fetus Disorder
- Keywords
- Sufentanil, Ropivacaine, Labor analgesia, Color Doppler ultrasound, Middle cerebral artery, Uterine artery, Umbilical artery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Jinan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 25 Oct 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.
Background: The purpose of this study was to see how intrathecal injections of sufentanil, ropivacaine, and sufentanil added to ropivacaine affected blood flow in the uterine artery, umbilical artery, and middle cerebral artery for combined spinal and epidural labor analgesia using color doppler ultrasound (CDUs).
Methods: A total of 90 singleton full-term parturients who were evaluated by obstetricians for feasible vaginal delivery were collected prospectively and divided into three groups based on the randomization and double-blind principle: sufentanil (S), ropivacaine (R) group, each with 30 cases. Main indicators include color doppler blood flow resistance indices (S/D) of the uterine artery (UtA), umbilical artery (UA), and middle cerebral artery (MCA) before (T0) and 30 minutes (T1), 60 minutes (T2), 90minutes (T3) after analgesia. Fetal heart rate (FHR), maternal mean arterial pressure (MAP) at T0, T1, T2 and T3。
Detailed description
- Randomization and blinding Parturients in the study were randomly assigned to Sufentanil group (S) and Ropivacaine group (R) by non-blind personnel according to the computer random number table, and the allocation was hidden. The solution was prepared by an unblinded anesthesiologist and packaged in a blind way and administered by another anesthesiologist. The patients, anesthesia providers, data recorders, ultrasound examiners, obstetrical staff, and nursing staff remained blinded to group assignment throughout the study.
- Study intervention At the time of request for labor analgesia, patients were randomized to receive either sufentanil 5 μg (Group S) and ropivacaine 3mg (Group R) into the subarachnoid space. All groups received the standard epidural solution that contained 0.1% ropivacaine with 0.25 μg/ml sufentanil. Routine obstetric and anaesthetic monitoring was given after maternal entered the delivery room. An experienced the anesthesiologist select L3-4 lumbar vertebra clearance to puncture with standard sterile technique using loss of resistance when the puerpera palace has expanded to about 3 cm. After the puncture reached the epidural space, a 25-gauge lumbar anesthesia needle was used to puncture into the subarachnoid space. 2 mL of anesthetic drug as determined by her group randomization were administered into the cavity through the lumbar anesthesia needle after cerebrospinal fluid flow out. A 19-gauge spring-wound catheter was threaded 4-6 cm into the epidural space. All patients received a test dose of 3 ml of 1.5% lidocaine followed by an initial loading dose of 5 ml of the standard epidural solution. Epidural catheters into vessels or subarachnoid space were excluded. An analgesic pump (PCEA pump, 100ml) containing standard epidural solution was then connected to the epidural catheter at a background continuous infusion rate of 5 mL/h. The visual analogue score for pain (VAS) was performed 15 minutes after the injection dose, and if the VAS score fell below 3, the case was included in the study. An anesthesia provider assessed the adequacy of analgesia for the patients throughout the duration of labor. Any breakthrough pain was managed with a physician-administered epidural bolus. All obstetric analgesia procedures were performed by the same anesthesiologist to reduce errors due to technical reasons.
- Ultrasonic examination method The patients were placed in a supine position with calm breathing to perform doppler ultrasonography during the interval of contractions. Ultrasound probe was placed on fetal head area. Middle cerebral arteries (MCA) run anteriorly on both sides of the ring of cerebral arteries at the position of the double head diameter (see Figure 1A). We can get waveforms of MCA examined by pulsed wave doppler (see Figure 1B). The probe was placed at the placenta area, and we can see the fetal umbilical cord connecting to the center of the placenta. Umbilical artery (UA) could be identified by color flow, and its waveforms were examined by pulsed wave doppler (see Figure 1C and 1D). The probe was placed at the midpoint of the groin. The right and left uterine arteries (UtA) could be identified by color flow at the apparent crossover with the external iliac arteries, and pulsed wave doppler was used to obtain waveforms (see Figure 1E and 1F). 3 to 10 arterial spectrograms with clear edges and no background noise at baseline were selected. The above arterial blood flow indexes were measured three times and the average value was taken. The S/Dvalue of MCA、UA、UtA can be measured automatically by ultrasound instrument. All doppler examinations were performed by the same sonographer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | – | Drug: sufentanil, ropivacaineintrathecal injections of sufentanil |
| Group R | – | Drug: sufentanil, ropivacaineintrathecal injections of ropivacaine |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- ASA grade I to II, aged 20 to 35 years, weighing 50 to 100 kg, 150-175 cm in height, and 37 to 41 weeks of gestation
Key inclusion criteria (5 listed)
- ASA grade I to II
- Aged 20 to 35 years
- Weighing 50 to 100 kg
- 150-175 cm in height
- 37 to 41 weeks of gestation
Key exclusion criteria (6 listed)
- Women with contraindications of spinal anesthesia
- Maternal complications (such as pregnancy-induced hypertension, preeclampsia, cardiovascular and cerebrovascular diseases, etc.)
- Abnormal uterine contractions
- Abnormal placental function or position
- Signs of fetal distress
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 |
|---|---|---|
| sufentanil, ropivacaineAlso: Color Doppler ultrasoundThe study used conventional anesthetic drugs to compare the effects of the two drugs on maternal and infant blood flow | Drug | Group R, Group S |
Primary outcome
color doppler blood flow resistance indices (S/D）
Time frame: S/D measured before analgesia and 30 minutes, 60 minutes, 90minutes after analgesia
S/D is an abbreviation for systolic/diastolic blood pressure.The patients were placed in a supine position with calm breathing to perform Doppler ultrasonography during the interval of contractions.
2 secondary outcomes
FHR
Time frame: Fetal heart rate measured before analgesia and 30 minutes, 60 minutes, 90minutes after analgesia
MAP
Time frame: Mean arterial pressure before analgesia and 30 minutes, 60 minutes, 90minutes after analgesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
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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.
Xuemei Peng, Ph.d principal investigator
First Affiliated Hospital of Jinan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Pain and Analgesia, run by First Affiliated Hospital of Jinan University at 1 site in China.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 25 Oct 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 China. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
color doppler blood flow resistance indices (S/D） (time frame: S/D measured before analgesia and 30 minutes, 60 minutes, 90minutes after analgesia). 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 25 Oct 2023.