Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
ID07076368

Determination of the 90% Effective Volume of Epidural 0.1% Ropivacaine and Fentanyl for Labor Pain Relief Using a Dural-Puncture Epidural Technique

Led by University of California, San Francisco · Updated on 2026-01-27

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to find the best dose of a medicine mixture to provide quick pain relief within 30 minutes during labor using an epidural. It focuses on women in active labor who are receiving a dural-puncture epidural technique for pain relief. The study also examines any side effects from the epidural medication and how satisfied patients are with their pain relief experience. The study involves giving a combined epidural medication made of 0.1% ropivacaine and 2 mcg/ml fentanyl to participants. Researchers will use a special method to determine the volume of this mixture that works effectively for 90% of patients during labor. The study will observe one group of 50 patients who meet the criteria and are receiving this epidural technique. Participants will be monitored closely during labor after receiving the epidural medication. Researchers will measure pain levels 30 minutes after the epidural is given using a numerical pain score. They will also watch for any medication side effects and collect feedback on satisfaction with pain relief. The study is planned to start in October 2025 and continue until July 2026, involving women aged 18 or older with single pregnancies in active labor.

CONDITIONS

Brief Title

Ropivacaine and Fentanyl for Labor Epidural Initiation

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Significant obstetric disease such as pre-eclampsia or major cardiac disease
  • Chronic pain or chronic opioid use
  • Body mass index (BMI) of 50 or higher
  • Multiple pregnancies (twins or more)
  • Allergy or severe reaction to local anesthetics
  • Signs of fetal distress or non-reassuring fetal heart tracing
  • Age under 18
  • Inability to speak or understand English or Spanish

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) to confirm eligibility before labor

Treatment

Duration - During active labor until delivery

Participants receive a dural-puncture epidural with a combined 0.1% ropivacaine and 2 mcg/ml fentanyl regimen for labor pain relief.

1 visit during labor for epidural administration and monitoring

Trial Site Locations

Total: 1 location

1

University of California, San Francisco

San Francisco, California, United States, 94158

Actively Recruiting

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Research Team

A

Alexander Butwick, MBBS, FRCA, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial.

Anthony Chau, Carolina Bibbo, Chuan-Chin Huang...

https://pubmed.ncbi.nlm.nih.gov/28067707

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.

Yujie Song, Yingcai Song, Zhihao Sheng...

https://pubmed.ncbi.nlm.nih.gov/39433721

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.

Ayumi Maeda, Diego Villela-Franyutti, Mario I Lumbreras-Marquez...

https://pubmed.ncbi.nlm.nih.gov/37824436