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Epidural Blood Patch on the Resolution of Postdural Puncture Headache (PDPH)

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ClinicalTrials.gov Identifier: NCT00373074
Recruitment Status : Terminated (Lack of subject population for PI)
First Posted : September 7, 2006
Last Update Posted : February 6, 2009
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston

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?"

Condition or disease Intervention/treatment Phase
Post-Lumbar Puncture Headache Other: Epidural Blood Patch Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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)
Study Start Date : September 2006
Estimated Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Active Comparator: 15 cc
15 cc of blood used for Epidural Blood Patch
Other: Epidural Blood Patch
Use 15 cc of blood

Active Comparator: 20 cc
20 cc of blood used for Epidural Blood Patch
Other: Epidural Blood Patch
Inject 20 cc of blood into epidural space

Active Comparator: 30 cc
30cc of blood used for Epidural Blood Patch
Other: Epidural Blood Patch
Inject 30 cc of autologous blood




Primary Outcome Measures :
  1. The site of headache [ Time Frame: After epidural puncture ]
  2. Associated symptoms of headache [ Time Frame: after epidural puncture ]
  3. The severity of and the degree of functional impairment from the post-dural puncture headache [ Time Frame: after epidural puncture ]
  4. The back discomfort experienced before, during, and after injection of blood [ Time Frame: before, during and after injection of blood ]
  5. Complete or partial success at relieving headache [ Time Frame: After blood patch ]

Secondary Outcome Measures :
  1. The circumstances of the unintentional dural puncture [ Time Frame: during epidural placement ]
  2. Type of delivery [ Time Frame: during delivery ]
  3. History of migraine headache [ Time Frame: before epidural placement ]
  4. The time to onset of headache [ Time Frame: After epidural placement ]
  5. Use of analgesics & other symptomatic medication [ Time Frame: After post dural puncture headache ]
  6. The duration from dural puncture to EBP (NB. must be 24 h to 120 h) [ Time Frame: 24 to 120 hours ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373074


Locations
United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030
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

Responsible Party: Nicholas Lam, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00373074     History of Changes
Other Study ID Numbers: HSC-MS-06-0220
First Posted: September 7, 2006    Key Record Dates
Last Update Posted: February 6, 2009
Last Verified: February 2009

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

Additional relevant MeSH terms:
Headache
Wounds and Injuries
Post-Dural Puncture Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases