Status:
WITHDRAWN
Epidural Blood Patch on the Resolution of Postdural Puncture Headache (PDPH)
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Post-Lumbar Puncture Headache
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to address the question, "What is the volume of blood for injection at epidural blood patch that most effectively relieves post-dural puncture headache?"
Detailed Description
Accidental dural puncture is the most common (rate 1 in 50-250 in most obstetric hospitals) and, arguably, important complication of epidural insertion. After breach of the dura with a 16-18 gauge epi...
Eligibility Criteria
Inclusion
- Obstetric patients aged 18 or more years
- Post-dural puncture headache (PDPH) after a confirmed or likely unintentional dural puncture with an epidural needle. PDPH is defined as " A headache with clear postural characteristics (onset or significant exacerbation when erect and relieved or significantly diminished by lying flat). The diagnosis is supported by distribution in the frontal or occipital region, with associated neck ache."
- Medically suitable for and have consented to epidural blood patch (EBP) for treatment of PDPH
Exclusion
- Previous epidural blood patch (EBP) related to the same unintentionl dural puncture (including prophylactic EBP)
- EBP to be performed more than 5 days after the unintentional dural puncture.
- History of significant low or radicular back pain (requiring treatment) during pregnancy
- Women in whom a further dural puncture occurs at the time of epidural needle insertion for the EBP
- Diagnosis other than PDPH subsequently confirmed.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00373074
Start Date
September 1 2006
End Date
July 1 2008
Last Update
November 5 2020
Active Locations (1)
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1
Memorial Hermann Hospital
Houston, Texas, United States, 77030