Ropivacaine and Fentanyl for Labor Epidural Initiation

NCT07076368 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 25-43988
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Analgesia; Pregnancy; Labor and Delivery

Keywords

epidural; labor analgesia; pregnancy; obstetric anesthesia

Outcome Measures

Primary Outcomes (1)

• Numerical Pain score

  Numerical pain score using a discrete range from 0 (no pain) to 10 (most severe pain).

  30 mins post-intervention

Study Arms (1)

Observational Cohort

EXPERIMENTAL

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

Drug: Ropivacaine + Fentanyl

Interventions

Ropivacaine + Fentanyl DRUG

A standard epidural admixture - 0.1% Ropivacaine + 2 mcg/ml fentanyl - will be used.

Observational Cohort

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant birthing patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

RECRUITING

Related Publications (3)

• Chau A, Bibbo C, Huang CC, Elterman KG, Cappiello EC, Robinson JN, Tsen LC. Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial. Anesth Analg. 2017 Feb;124(2):560-569. doi: 10.1213/ANE.0000000000001798.

  PMID: 28067707 BACKGROUND

• Song Y, Song Y, Sheng Z, Zhao Q, Liu W, Li Y, Zang Y, Xu Z, Liu Z. Exploration of the optimal programmed intermittent epidural bolus volume with the dural puncture epidural technique for labour analgesia: a biased-coin up-and-down sequential allocation study. Can J Anaesth. 2025 Feb;72(2):254-261. doi: 10.1007/s12630-024-02855-6. Epub 2024 Oct 21.

  PMID: 39433721 BACKGROUND

• Maeda A, Villela-Franyutti D, Lumbreras-Marquez MI, Murthy A, Fields KG, Justice S, Tsen LC. Labor Analgesia Initiation With Dural Puncture Epidural Versus Conventional Epidural Techniques: A Randomized Biased-Coin Sequential Allocation Trial to Determine the Effective Dose for 90% of Patients of Bupivacaine. Anesth Analg. 2024 Jun 1;138(6):1205-1214. doi: 10.1213/ANE.0000000000006691. Epub 2023 Oct 12.

  PMID: 37824436 BACKGROUND

MeSH Terms

Interventions

Ropivacaine; Fentanyl

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Alexander Butwick, MBBS, FRCA, MS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Butwick, MBBS, FRCA, MS

CONTACT

415-514-3757; alexander.butwick@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-center, double-blind, prospective study that will use a biased-coin-up-down allocation study design to quantify the effective volume in 90% of laboring patients (EDV) after a dural-puncture epidural (DPE) technique for neuraxial analgesia. We wish to declare that the participant, care providers, and outcomes assessor will be masked. The ClinicalTrials website does not allow us to tick these roles for a single-arm study.

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 22, 2025
• Study Start: October 24, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)