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2 Dose Neuraxial Morphine for Prevention of PDPH

NCT02473276 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-02-05

Study results available
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Summary

Neuraxial analgesia (most commonly continuous epidural or combined spinal epidural) is the most effective modality available for pain relief during labor. Accidental dural puncture (ADP) with a large bore epidural needle and the resulting post-dural puncture headache (PDPH) is one of the most significant sources of anesthesia-related morbidity in parturients.

Epidural blood patch (EBP) is the gold standard for treatment of PDPH, and although almost always effective, can result in another ADP, as well as low back pain and lower extremity pain. For this reason, effective measures to prevent PDPH when ADP occurs would be highly valuable. One small study in which 50 women were randomly allocated to receive 2 epidural injections of morphine or saline, demonstrated a beneficial effect of epidural morphine in decreasing the incidence of PDPH.

This study aims to determine the efficacy of 2 doses of neuraxial (either epidural (EPID) or intrathecal) preservative-free morphine (PFM) to prevent headache after ADP in parturients.

Conditions

  • Postdural Puncture Headache

Interventions

DRUG

Morphine

preservative free morphine given either via an epidural or intrathecal catheter

DRUG

Sterile normal saline

sterile normal saline, given either via an epidural or intrathecal catheter

Sponsors & Collaborators

  • Montefiore Medical Center

    collaborator OTHER

  • Rutgers University

    collaborator OTHER

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Columbia University

    lead OTHER

Principal Investigators

  • Richard Smiley, MD, PhD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02473276 on ClinicalTrials.gov