Ropivacaine and Fentanyl for Labor Epidural Initiation

Not Applicable

Not yet recruiting

• Conditions: Pregnancy; Labor and Delivery; Labor Analgesia
• Interventions: Drug: Ropivacaine + Fentanyl

• Registration Number: NCT07076368
• Lead Sponsor: University of California, San Francisco

Brief 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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-07
• Study First Submitted QC: 2025-07-14
• Last Update Submitted: 2025-07-14
• Study First Posted: 2025-07-22
• Last Update Posted: 2025-07-22
• Study Start: 2025-08-31
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Observational Cohort	Ropivacaine + Fentanyl	Patients with singleton vertex pregnancies in active labor (spontaneous or after induction of labor), with a cervical dilatation between 1 and 7cm who are requesting neuraxial labor analgesia, Age =\>18 yrs

Primary Outcome Measures

Name	Time	Method
Numerical Pain score	30 mins post-intervention	Numerical pain score using a discrete range from 0 (no pain) to 10 (most severe pain).

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States