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Local Anesthetic
Epidural Bupivacaine for Labor Pain
Phase 4
Recruiting
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
Study Summary
This trial found that the ED90 of bupivacaine via the epidural technique is 3.65 milligrams in women undergoing labor after receiving a lidocaine test dose.
Who is the study for?
This trial is for women in labor at term (37-42 weeks) with a single baby positioned head down, who want epidural pain relief and have moderate to severe pain. They should be less than 5 cm dilated and without major health issues or conditions that increase the risk of cesarean delivery.Check my eligibility
What is being tested?
The study aims to find the right dose of bupivacaine, an anesthetic drug given through the back into the epidural space, which can effectively reduce labor pain in 90% of patients after they've had a lidocaine test dose.See study design
What are the potential side effects?
Possible side effects include discomfort at injection site, lower blood pressure, numbness or weakness in legs, headache from leakage of spinal fluid (rare), and rarely nerve damage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Dural Puncture Epidural TechniqueExperimental Treatment1 Intervention
Laboring women receiving the Dural Puncture Epidural (DPE) Technique, after a lidocaine "test dose", with dose of Bupivacaine 0.25% diluted to 20 mL with isotonic sterile 0.9% saline. The first subject in the DPE group will receive an initial dose of bupivacaine 25 mg, with an endpoint being the achievement of an NRS < 3 at 30 min. Subsequent patients are administered bupivacaine doses determined by the response of the previous subject, as per the biased coin method. The subsequent up and down interval doses are bupivacaine 2.5 mg (1 mL) increments, with an anticipated dose range from 20 mg to 40 mg.
Group II: Epidural TechniqueActive Control1 Intervention
Laboring women receiving the Conventional Epidural Technique (EPL), after receiving a lidocaine "test dose" with dose of Bupivacaine 0.25% diluted to 20 mL with isotonic sterile 0.9% saline. The first subject in the EPL group will receive an initial dose of bupivacaine 25 mg, with an endpoint being the achievement of an NRS < 3 at 30 min. Subsequent patients are administered bupivacaine doses determined by the response of the previous subject, as per the biased coin method. The subsequent up and down interval doses are bupivacaine 2.5 mg (1 mL) increments, with an anticipated dose range from 20 mg to 40 mg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine Hydrochloride
2020
Completed Phase 4
~1420
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,612 Previous Clinical Trials
11,470,455 Total Patients Enrolled
3 Trials studying Labor Pain
340 Patients Enrolled for Labor Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant with one baby, and the baby is positioned head-down and expected to be born between 37 and 42 weeks.You have severe pain when asking for epidural pain relief during labor.I want to have an epidural for pain relief during labor.I have a condition that might require a cesarean delivery, but I'm eligible for a trial of labor after cesarean.You have had a bad reaction to a certain type of numbing medicine before.There are signs that the baby may have health problems before birth.Your cervix is not dilated more than 5 centimeters.I cannot have an epidural due to health reasons.I am pregnant and do not have any major health issues.I have or had a serious health condition, including pregnancy-related issues.
Research Study Groups:
This trial has the following groups:- Group 1: Dural Puncture Epidural Technique
- Group 2: Epidural Technique
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any more openings available for participation in this clinical research?
"As per clinicaltrials.gov, the trial that was initially posted on October 1st 2022 is no longer looking to recruit patients at this time. However, there are 133 other trials open for patient enrollment presently."
Answered by AI
Is Bupivacaine Hydrochloride viable for human use without any detrimental side effects?
"Bupivacaine Hydrochloride has been approved, undeniably establishing its safety and thus receiving a score of 3."
Answered by AI
Might I be eligible to participate in this experiment?
"This trial is open to 120 individuals aged 18-50 who suffer from anodynia. In addition, singleton mothers with vertex pregnancies between 37 and 42 weeks of gestation that lack major comorbidities, have a dilation below 5 cm and are seeking epidural labor analgesia must display a numerical rating scale (NRS) score greater or equal to five on the 0-10 pain intensity scale at request time."
Answered by AI
Is the age limit for trial participants higher than fifty-five?
"This study is only suitable for participants aged between 18 and 50, in accordance with the inclusion criteria."
Answered by AI
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