NCT00373074

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?"

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

1.8 years

First QC Date

September 5, 2006

Last Update Submit

November 3, 2020

Conditions

Post-Lumbar Puncture Headache

Keywords

Spinal Puncture Headache

Outcome Measures

Primary Outcomes (5)

  • The site of headache

    After epidural puncture

  • Associated symptoms of headache

    after epidural puncture

  • The severity of and the degree of functional impairment from the post-dural puncture headache

    after epidural puncture

  • The back discomfort experienced before, during, and after injection of blood

    before, during and after injection of blood

  • Complete or partial success at relieving headache

    After blood patch

Secondary Outcomes (6)

  • The circumstances of the unintentional dural puncture

    during epidural placement

  • Type of delivery

    during delivery

  • History of migraine headache

    before epidural placement

  • The time to onset of headache

    After epidural placement

  • Use of analgesics & other symptomatic medication

    After post dural puncture headache

  • +1 more secondary outcomes

Study Arms (3)

15 cc

ACTIVE COMPARATOR

15 cc of blood used for Epidural Blood Patch

Other: Epidural Blood Patch

20 cc

ACTIVE COMPARATOR

20 cc of blood used for Epidural Blood Patch

Other: Epidural Blood Patch

30 cc

ACTIVE COMPARATOR

30cc of blood used for Epidural Blood Patch

Other: Epidural Blood Patch

Interventions

Epidural Blood PatchOTHER

Use 15 cc of blood

15 cc

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Blood Patch, Epidural

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeuticsInjections, EpiduralInjections, SpinalInjectionsDrug Administration RoutesDrug Therapy

Study Officials

  • Nicholas C.K. Lam, M.D.

    University of Texas Medical School at Houston

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2006

First Posted

September 7, 2006

Study Start

September 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations

US(1)