Epidural Blood Patch on the Resolution of Postdural Puncture Headache (PDPH) - Full Text View

Sponsored by:	The University of Texas Health Science Center, Houston
Information provided by:	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00373074

Purpose

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?"

Condition	Intervention	Phase
Post-Lumbar Puncture Headache	Other: Epidural Blood Patch	Phase II Phase III

MedlinePlus related topics: Headache

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Randomized Controlled Study Trial to Investigate the Effect of Varying Volumes of Blood Patch on the Resolution of Postdural Puncture Headache (PDPH)

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

The site of headache [ Time Frame: After epidural puncture ] [ Designated as safety issue: No ]
Associated symptoms of headache [ Time Frame: after epidural puncture ] [ Designated as safety issue: No ]
The severity of and the degree of functional impairment from the post-dural puncture headache [ Time Frame: after epidural puncture ] [ Designated as safety issue: No ]
The back discomfort experienced before, during, and after injection of blood [ Time Frame: before, during and after injection of blood ] [ Designated as safety issue: No ]
Complete or partial success at relieving headache [ Time Frame: After blood patch ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The circumstances of the unintentional dural puncture [ Time Frame: during epidural placement ] [ Designated as safety issue: No ]
Type of delivery [ Time Frame: during delivery ] [ Designated as safety issue: No ]
History of migraine headache [ Time Frame: before epidural placement ] [ Designated as safety issue: No ]
The time to onset of headache [ Time Frame: After epidural placement ] [ Designated as safety issue: No ]
Use of analgesics & other symptomatic medication [ Time Frame: After post dural puncture headache ] [ Designated as safety issue: No ]
The duration from dural puncture to EBP (NB. must be 24 h to 120 h) [ Time Frame: 24 to 120 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2006
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
15 cc: Active Comparator 15 cc of blood used for Epidural Blood Patch	Other: Epidural Blood Patch Use 15 cc of blood
20 cc: Active Comparator 20 cc of blood used for Epidural Blood Patch	Other: Epidural Blood Patch Inject 20 cc of blood into epidural space
30 cc: Active Comparator 30cc of blood used for Epidural Blood Patch	Other: Epidural Blood Patch Inject 30 cc of autologous blood

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373074

Contacts

Contact: Nicholas C.K. Lam, MD

research@memorialhermann.org

Locations

United States, Texas
Memorial Hermann Hospital	Recruiting
Houston, Texas, United States, 77030
Contact: Nicholas C.K. Lam, M.D. research@memorialhermann.org
Sub-Investigator: Peter Doyle, MD
Sub-Investigator: Moeen Panni, MD, PhD
Sub-Investigator: Didier Sciard, MD

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

Principal Investigator:

Nicholas C.K. Lam, M.D.

University of Texas Medical School at Houston

More Information

Responsible Party:	The University of Texas Health Science Center, Houston ( Nicholas Lam )
Study ID Numbers:	HSC-MS-06-0220
Study First Received:	September 5, 2006
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00373074
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:

Spinal Puncture Headache

Study placed in the following topic categories:

Post-Dural Puncture Headache
Signs and Symptoms
Headache Disorders, Secondary
Headache
Neoplasm Metastasis

Central Nervous System Diseases
Neurologic Manifestations
Pain
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009