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NCT Number: NCT07684365

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

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Key information

Conditions

Labor Pain and to Reduce Pain Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Dose of medication delivered using a programmed intermittent epidural bolus

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Amis

CONTACT

[email protected]

(617) 667-1861

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

Impact of Injected Volume on Programmed Intermittent Epidural Bolus Analgesia

Acronym: EpiVol

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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