Best starting dose of ropivacaine with fentanyl for epidural pain relief during labor
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
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 |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07076368 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
San Francisco, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.