Ropivacaine and Fentanyl for Labor Epidural Initiation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-24

Study Completion Date

2026-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pregnancy Labor and Delivery Labor Analgesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Observational Cohort

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

Group Type EXPERIMENTAL

Ropivacaine + Fentanyl

Intervention Type DRUG

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

Interventions

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Ropivacaine + Fentanyl

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No