This study is not yet accepting patients

Ropivacaine and Fentanyl for Labor Epidural Initiation

a study on Pregnancy Labor and Delivery Labor Analgesia

Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at San Francisco 5391959, California 5332921
Dates
study started
study ends around
Principal Investigator
by Alexander Butwick, MBBS, FRCA, MS
Headshot of Alexander Butwick
Alexander Butwick

Description

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.

Official 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

Details

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.

Keywords

Pregnancy, Labor and Delivery, Labor Analgesia, epidural, obstetric anesthesia, Ropivacaine, Fentanyl, Ropivacaine + Fentanyl

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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 CAN'T join 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

Location

  • UCSF
    San Francisco 5391959 California 5332921 94158 United States

Lead Scientist at UCSF

  • Alexander Butwick, MBBS, FRCA, MS
    I study how we can close the gap between what we know and what we do in managing severe maternal complications such as postpartum hemorrhage. My research focuses on developing strategies to improve clinical preparedness, response, and decision-making in the prevention and management of postpartum hemorrhage.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07076368
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 50 study participants
Last Updated