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

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: Labor Pain and to Reduce Pain
• Intervention / Treatment: Drug: administration of bupivacaine 7.5 mg and fentanyl 24 mcg every 40 minutes

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

• Study Contact: Name: Elizabeth Amis; Phone Number: (617) 667-1861; Email: eamis@bidmc.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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

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

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 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): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: fentanyl; epidural analgesia; bupivacaine; labor pain; Obstetric anesthesia; programmed intermittent epidural bolus
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Labor Pain; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Fentanyl
• 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