CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 44 enrolled
Drug / intervention
Morphine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02473276
NCT02473276Phase 4Completed

Two Dose Neuraxial Morphine for Prevention of Postdural Puncture Headache

Columbia University·interventional·Posted Jun 16, 2015·Updated Feb 5, 2025

In Brief

A Phase 4 clinical trial evaluating Morphine and Sterile normal saline for Postdural Puncture Headache. Completed, enrolled 44 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 16, 2015
Enrollment StartSep 1, 2015
Primary CompletionJan 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 11.0 years ago

Interventions

Morphinedrug

preservative free morphine given either via an epidural or intrathecal catheter

Sterile normal salinedrug

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