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

This study has been terminated.
(Lack of subject population for PI)
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00373074
First received: September 5, 2006
Last updated: February 4, 2009
Last verified: February 2009
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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)

Resource links provided by NLM:


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: 0
Study Start Date: September 2006
Study Completion Date: July 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Study First Received: September 5, 2006
Last Updated: February 4, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 30, 2014