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Post Dural Puncture Headache After Accidental Dural Puncture

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lynn Haslam, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01448590
First received: October 5, 2011
Last updated: October 6, 2011
Last verified: October 2011
History of Changes
  Purpose

Epidural anesthesia is associated with potential risks and complications, post dural puncture headache (PDPH) one of the most recognized with epidural or spinal anesthesia. Accidental dural punctures occur with approximately 1.5% of all epidural attempts. Studies have suggested that the use of an intrathecal catheter reduces the incidence of PDPH. A systematic review of the existing literature will identify if there is reliable evidence to support this theory. A secondary outcome, headache severity, will also be explored via incidence rates of epidural blood patch, as this intervention is performed as a treatment for the most severe headaches.


Condition
Post Dural Puncture Headache

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Systematic Review: Post Dural Puncture Headache After Accidental Dural Puncture: Does Insertion of Spinal Catheter Decrease Incidence of Headaches?

Resource links provided by NLM:

MedlinePlus related topics: Headache
U.S. FDA Resources

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Number of PDPH after epidural resite versus Number of PDPH after insertion of epidural catheter into spinal space [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Review of literature that compares two interventions - resiting the epidural or insertion of epidural catheter into spinal space. The Primary outcome measure will be the number of post dural puncture headache events in each group.


Secondary Outcome Measures:
  • What is the incidence of epidural blood patches (EBP)? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Looking at the incidence of EBP in the spinal catheter group, in comparison to the resited epidural group.


Estimated Enrollment: 1
Study Start Date: June 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Epidural Resite
After ADP, those patients who receive an epidural resite.
Spinal catheter
After ADP, those who receive the epidural catheter into the spinal space

Detailed Description:

Post dural puncture headache (PDPH) is one of the recognized complications experienced with epidural or spinal anesthesia, resulting from needle puncture of the dura layer of the meninges. This puncture can be deliberate (during spinal anesthesia) or accidental (during epidural anesthesia). Dural punctures allow a leak of cerebrospinal fluid, leading to the characteristic syndrome of PDPH; also known as a spinal headache or low-pressure headache. Accidental dural punctures occur with approximately 1.5% of all epidural attempts. Studies have estimated that, within the obstetrical population, headaches resulting from an inadvertent dural puncture are as high as 50% to 75%.

As the risk of accidental dural punctures (ADP) cannot be eliminated, research has focused on possible interventions that may be taken in order to avoid the onset of a PDPH, eliminate its severity, or treat effects. One of the most common and effective treatments being an epidural blood patch (EBP). More recently, threading the epidural catheter directly into the intrathecal space after the dural puncture has been recognized as a viable option.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Obstetrical population

Criteria

Inclusion Criteria:

  • any comparative methodology, including case-control studies, cohort studies, randomized clinical trials, and chart reviews.
  • Insertion of the epidural catheter into the intrathecal space at the level of dural puncture, was compared to resiting an epidural catheter at another level

Exclusion Criteria:

  • Any intentional dural punctures (spinal anesthesia) or use of spinal microcatheters were excluded
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448590

Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Lynn Haslam, RN MN/ACNP Sunnybrook Health Sciences Centre, Toronto
Principal Investigator: Eric Goldszmidt, MD FRCPC Mount Sinai Hospital, Toronto
  More Information

No publications provided

Responsible Party: Lynn Haslam, Nurse Practitioner, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01448590     History of Changes
Other Study ID Numbers: SHSC-Haslam-PDPH
Study First Received: October 5, 2011
Last Updated: October 6, 2011
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
post dural puncture headache
accidental dural puncture
PDPH
ADP
spinal catheter
 epidural catheter
intrathecal catheter
dural puncture
systemic review

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 May 16, 2013