Ropivacaine and Fentanyl for Labor Epidural Initiation (EV90_DPE)

University of California San Francisco (UCSF)

Status and phase: Enrolling; Phase 3

Conditions: Labor Analgesia; Labor and Delivery; Pregnancy

Treatments: Drug: Ropivacaine + Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT07076368

25-43988

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Observational Cohort

Experimental group

Description:

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

Treatment:

Drug: Ropivacaine + Fentanyl