NCT07076368

Ropivacaine and Fentanyl for Labor Epidural Initiation

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to determine the most effective dose of medicine to use to initially provide effective pain relief within the first 30 minutes of receiving an epidural for pain labor during labor. The study team will also study any side effects related to the epidural medication and patients' satisfaction with the quality of pain relief after receiving the epidural.

Detailed description

We aim to perform a prospective observational study in a single cohort of 50 patients receiving a dural-puncture epidural technique for labor analgesia. We will use a biased-coin up-down allocation methodology to quantify the volume of a combined epidural 0.1% ropivacaine and 2 mcg/ml fentanyl regimen that achieves effective analgesia in 90% of patients experiencing active labor who receive a dural-puncture epidural technique for labor analgesia.

Conditions

• Pregnancy
• Labor and Delivery
• Labor Analgesia

Interventions

Type	Name	Description
DRUG	Ropivacaine + Fentanyl	A standard epidural admixture - 0.1% Ropivacaine + 2 mcg/ml fentanyl - will be used.

Timeline

• Start date: 2025-10-24
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2025-07-22
• Last updated: 2026-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study