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NCT Number: NCT07076368

Ropivacaine and Fentanyl for Labor Epidural Initiation

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.

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Key information

Conditions

Pregnancy Labor Analgesia Labor and Delivery

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of California, San Francisco

San Francisco, California, 94158, United States

Location status: Recruiting

Location contact

Alexander Butwick

CONTACT

[email protected]

415-514-3757

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine + Fentanyl

Drug

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

Primary outcomes

  1. Numerical Pain score

    Time frame: 30 mins post-intervention

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

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Butwick, MBBS, FRCA, MS

CONTACT

[email protected]

415-514-3757

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Acronym: EV90_DPE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2025
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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