Best starting dose of ropivacaine with fentanyl for epidural pain relief during labor
Official title: Determination of the 90% Effective Volume (ED90) of Epidural 0.1% Ropivacaine and Fentanyl for Labor Analgesia Initiation in Patients Receiving a Dural-Puncture Epidural Technique
Run by University of California, San Francisco · NCT07076368 · Data updated 2026-11-12
This trial tests different starting doses of ropivacaine with fentanyl to see which one gives effective pain relief within 30 minutes for people in active labor.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Status | Recruiting |
| Started | October 24, 2025 |
| Main results expected | July 31, 2026 |
| Study ends | July 31, 2026 |
| Registry record updated | January 27, 2026 |
| Trial ID | NCT07076368 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with a singleton vertex pregnancy in active labor (cervical dilation 2–7 cm) requesting neuraxial labor analgesia and able to communicate in English or Spanish are ideal candidates.
✕Probably not a fit
Patients with significant obstetric disease (e.g., pre-eclampsia, major cardiac disease), chronic pain or chronic opioid use, BMI ≥ 50, multiple gestation, allergy to local anesthetic, fetal compromise, age under 18, or inability to speak English or Spanish are unlikely to qualify or receive benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational single-cohort study enrolling 50 laboring patients who receive a dural-puncture epidural technique. A biased-coin up-down allocation will be used to vary the volume of a combined epidural solution of 0.1% ropivacaine with 2 mcg/mL fentanyl to estimate the volume that achieves effective analgesia in 90% of patients. The team will record time to effective analgesia within the first 30 minutes, medication-related side effects, and patient satisfaction with pain relief. Findings will help define an optimal initial volume for faster and more reliable epidural analgesia using this technique.
Why it matters
Potential benefit: If successful, this could identify an initial epidural dose that provides faster, more reliable pain relief with fewer side effects and higher patient satisfaction.
How similar studies have gone: Dose-finding and up-down allocation methods have been used successfully in neuraxial anesthesia research, but applying a biased-coin method to this specific dural-puncture ropivacaine–fentanyl regimen is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with singleton vertex pregnancies in active labor (latent or spontaneous labor or after induction of labor) * Cervical dilatation between 2 and 7 cm * Requesting neuraxial labor analgesia * Age 18 or older Exclusion Criteria: * Significant obstetric disease (e.g., pre-eclampsia, major cardiac disease) * Chronic pain or chronic opioid use * BMI ≥ 50 * Multiple gestations * Allergy or anaphylaxis to local anesthetic * Fetal compromise or non-reassuring fetal trace * Age under 18 * Inability to speak and understand English or Spanish
Where it's running
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University of California, San Francisco
San Francisco, California, United States Recruiting
Study contacts
- Principal investigator: Alexander Butwick, MBBS, FRCA, MS — University of California, San Francisco
- Study coordinator: Alexander Butwick, MBBS, FRCA, MS
- Email: alexander.butwick@ucsf.edu
- Phone: 415-514-3757
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.