Ropivacaine + Fentanyl for Labor Pain Relief
(EV90_DPE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the optimal dosage of two medications, ropivacaine and fentanyl, for effectively relieving pain during labor. Researchers will assess the effectiveness of these medicines within the first 30 minutes of administering an epidural and will also evaluate any side effects and participant satisfaction with pain relief. The trial is suitable for pregnant individuals in active labor with a single baby, who have a cervical dilation between 2 and 7 cm, and are interested in receiving an epidural for pain relief. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to advancements in labor pain management.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you have chronic pain or use opioids regularly, you cannot participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining ropivacaine and fentanyl for labor pain relief is generally safe and well-tolerated. Studies have found that this combination reduces the risk of motor blocks, making it less likely to cause movement difficulties—a common concern with epidurals. No major differences in side effects were observed when comparing this combination to other similar treatments, suggesting it is a safe option. This combination is already approved for similar pain relief purposes, supporting its safety for use in humans.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about combining ropivacaine and fentanyl for labor pain relief because this approach might offer effective pain management with potentially fewer side effects. Unlike traditional epidurals, which often rely heavily on local anesthetics, this combination could provide strong analgesia with a lower dose of ropivacaine, reducing the risk of motor block. Fentanyl, a potent opioid, works synergistically with ropivacaine to enhance pain relief while allowing mothers to maintain more sensation and mobility during labor. This combination aims to offer a balanced and more comfortable experience for expecting mothers.
What evidence suggests that Ropivacaine and Fentanyl might be effective for labor pain relief?
Studies have shown that a mix of ropivacaine and fentanyl effectively relieves labor pain. This combination offers strong pain relief without excessive muscle weakness. Research indicates it works as well as other common pain relief options but with fewer side effects, such as muscle weakness. This allows patients to receive pain relief while maintaining mobility. Overall, this combination is both effective and safe for managing labor pain.12367
Who Is on the Research Team?
Alexander Butwick, MBBS, FRCA, MS
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for pregnant individuals seeking pain relief during labor who wish to receive an epidural. Participants must be at a stage of labor where epidural analgesia is appropriate, and they should not have any health conditions that would make receiving an epidural unsafe.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a dural-puncture epidural technique with 0.1% ropivacaine and fentanyl for labor analgesia
Follow-up
Participants are monitored for pain relief effectiveness and side effects 30 minutes post-intervention
What Are the Treatments Tested in This Trial?
Interventions
- Fentanyl
- Ropivacaine
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor