Does the Volume of Medication Affect the Success of Labor Epidural Analgesia (EpiVol)

September 30, 2026 updated by: Phillip Hess, Beth Israel Deaconess Medical Center

Impact of Injected Volume on Programmed Intermittent Epidural Bolus Analgesia

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, single blinded trial comparing epidural pain relief for labor when medications are delivered in one of two volumes/concentrations. Patients in each arm of the study will receive the same dose of medication, but one will be half as concentrated and twice the volume. The outcome will be the number of supplemental doses of medication that patients receive during labor via their patient-controlled analgesia button.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High volume low concentration

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

Dose of medication delivered using a programmed intermittent epidural bolus
Experimental: Low concentration high volume

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

Dose of medication delivered using a programmed intermittent epidural bolus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient controlled boluses received
Time Frame: The duration of labor until delivery of the neonate

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient controlled boluses requests
Time Frame: The duration of labor until delivery of the neonate

The number of patient controlled boluses requested by pressing the PCA button for additional pain relief
The duration of labor until delivery of the neonate
Physician administered epidural bolus
Time Frame: The duration of labor until delivery of the neonate

The number of times that a physician supplies additional medication for the control of pain
The duration of labor until delivery of the neonate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Investigators

  • Principal Investigator: Philip Hess, MD, Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 30, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 29, 2026

First Submitted That Met QC Criteria

July 2, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

October 5, 2026

Last Update Submitted That Met QC Criteria

September 30, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025P000941

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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