Does the Volume of Medication Affect the Success of Labor Epidural Analgesia

NCT07684365 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 2025P000941
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate whether changing the volume and concentration of a medication affects the quality of pain relief and the side effects associated with labor epidural analgesia.

Conditions

Labor Pain and to Reduce Pain

Keywords

epidural analgesia; Obstetric anesthesia; bupivacaine; fentanyl; programmed intermittent epidural bolus; labor pain

Outcome Measures

Primary Outcomes (1)

• Patient controlled boluses received

  The number of patient-controlled boluses received by the patient by pressing the patient-controlled analgesia (PCA) button for additional pain relief

  The duration of labor until delivery of the neonate

Secondary Outcomes (2)

• Patient controlled boluses requests

  The duration of labor until delivery of the neonate

• Physician administered epidural bolus

  The duration of labor until delivery of the neonate

Study Arms (2)

High volume low concentration

ACTIVE COMPARATOR

combination product: 0.0625% bupivacaine with 2 mcg fentanyl delivered in 12 ml bolused every 40 minutes

Drug: administration of bupivacaine 7.5 mg and fentanyl 24 mcg every 40 minutes

Low concentration high volume

EXPERIMENTAL

combination product: 0.125% bupivacaine with 4 mcg fentanyl delivered in 6 ml bolused every 40 minutes

Drug: administration of bupivacaine 7.5 mg and fentanyl 24 mcg every 40 minutes

Interventions

administration of bupivacaine 7.5 mg and fentanyl 24 mcg every 40 minutes DRUG

Dose of medication delivered using a programmed intermittent epidural bolus

High volume low concentration; Low concentration high volume

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age or older
• Gestational age of 36 weeks or greater
• American Society of Anesthesiology physical status 2
• Induction of labor or early labor (cervical dilation \< 6cm)
• Singleton gestation
• Vertex presentation

You may not qualify if:

• Preeclampsia
• Receiving magnesium sulfate
• Having received narcotics within 4 hours
• Multiple gestation
• Major fetal anomalies or demise
• Previous spine surgery
• Known major spine pathology
• Substance use disorder

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

MeSH Terms

Conditions

Labor Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Philip Hess, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Amis

CONTACT

(617) 667-1861; eamis@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share