Phase 4
N=44
2 Dose Neuraxial Morphine for Prevention of PDPH
Postdural Puncture Headache
Bottom Line
View on ClinicalTrials.gov: NCT02473276 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Number of Participants With Postdural Puncture Headache — 3; 4; 8; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Morphine (Drug); Sterile normal saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Columbia University
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Postdural Puncture Headache |
3; 4; 8; 10 | — |
| SECONDARY Number of Participants in Need for Epidural Blood Patch |
2; 2; 5; 7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subjects will be ASA I and II women aged 18 years and older, who are known to have had accidental dural puncture with an epidural needle during placement of neuraxial labor analgesia, and have either an intrathecal catheter or epidural catheter in place.
Exclusion Criteria
- Past history of headache syndromes- such as migraine and cluster headaches
- History of chronic pain syndromes
- Chronic opioid use
- Illicit drug use - e.g. marijuana, heroin
- Allergy to morphine
- Intrapartum or postpartum fever ≥ 38 ° C
- Coagulopathy
- Accidental removal of the epidural or intrathecal catheter
Data sourced from ClinicalTrials.gov (NCT02473276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.