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Led by Brigham and Women's Hospital · Updated on 2026-07-13
120
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the dose of bupivacaine needed to provide effective comfort in 90% of women undergoing labor induction or augmentation using epidural techniques. The study focuses on women who have received a lidocaine test dose and aims to determine the optimal bupivacaine dose for two epidural methods the Dural Puncture Epidural DPE technique and the Conventional Epidural EPL technique. This is a randomized, phase 4 trial to improve pain relief during labor. Participants are assigned to one of two groups those receiving the DPE technique or those receiving the EPL technique, both following a lidocaine test dose. Each group receives bupivacaine 0.25% diluted to 20 mL. The first participant in each group receives 25 mg of bupivacaine, with later doses adjusted in 2.5 mg increments based on the previous participants pain relief, aiming to find the dose that achieves a pain score less than 3 on the Numerical Rating Scale NRS within 30 minutes. During the study, participants will be monitored for pain relief effectiveness using the verbal Numerical Pain Rating Scale at 30 minutes after bupivacaine administration. Researchers will track the dose needed to achieve effective comfort in most participants. The study includes women aged 18 to 50 who are in early labor with a pain score of at least 5, and assessments will be made during labor analgesia initiation. The total participation lasts through labor analgesia initiation and dose adjustments as per study protocol.
CONDITIONS
ED90 of Epidural Bupivacaine With Lidocaine for the Initiation of Labor Analgesia
L
Lawrence C Tsen, MD
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Brigham and Women's Hospital
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Dural Puncture Epidural Technique | Standard Epidural Technique |
|---|---|---|
| What it is | A technique where the epidural space is accessed through a dural puncture, followed by administration of bupivacaine and lidocaine to achieve labor analgesia. | Traditional epidural technique using bupivacaine and lidocaine delivered through standard epidural placement for labor pain relief. |
| Role in study | Assigned as the investigational intervention arm evaluating potential improvement in analgesia quality. | Serves as the active comparator, representing established labor analgesia practice. |
| Primary use | Used for rapid and effective pain control during early active labor for eligible women. | Used for established labor pain relief in women requesting epidural analgesia. |
| How it is given or performed | Epidural space accessed with dural puncture; bupivacaine and lidocaine are administered for pain relief. | Standard epidural placement followed by injection of bupivacaine and lidocaine for analgesia. |
| Evidence status | Ongoing clinical trial investigating effectiveness for labor pain. Prior published studies suggest improved analgesia quality and fewer side effects compared to standard epidural, but findings require further confirmation. | Well-established technique for labor pain relief; multiple studies confirm effectiveness and safety. |
| Important limitations | Ongoing study results are not yet available. Prior studies note that the technique may have unique risks, such as higher rate of post-dural puncture headache or technical difficulty, and external evidence is still limited to small to moderate studies. | Although it is broadly effective and safe, epidural technique can occasionally result in incomplete analgesia, procedural risks, or complications such as hypotension or nerve block. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During labor analgesia initiation
Participants receive bupivacaine via one of two epidural techniques after a lidocaine test dose. The initial dose is 25 mg, adjusted in increments of 2.5 mg based on pain relief response aiming to achieve comfort within 30 minutes.
Visits as needed during labor
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Dan Benhamou, Caroline Ghosh, Frédéric J Mercier
https://pubmed.ncbi.nlm.nih.gov/14639153/Warwick D Ngan Kee, Floria F Ng, Kim S Khaw...
https://pubmed.ncbi.nlm.nih.gov/20613484/Anthony Chau, Carolina Bibbo, Chuan-Chin Huang...
https://pubmed.ncbi.nlm.nih.gov/28067707/Brigham and Women's Hospital
Lead Sponsor
