Post Dural Puncture Headache After Accidental Dural Puncture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01448590
Recruitment Status : Withdrawn
First Posted : October 7, 2011
Last Update Posted : October 13, 2016
Information provided by (Responsible Party):
Lynn Haslam, Sunnybrook Health Sciences Centre

Brief Summary:
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 or disease
Post Dural Puncture Headache

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.

Study Type : Observational
Actual Enrollment : 0 participants
Time Perspective: Retrospective
Official Title: Systematic Review: Post Dural Puncture Headache After Accidental Dural Puncture: Does Insertion of Spinal Catheter Decrease Incidence of Headaches?
Study Start Date : June 2011
Primary Completion Date : March 2016
Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Number of PDPH after epidural resite versus Number of PDPH after insertion of epidural catheter into spinal space [ Time Frame: 1 year ]
    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 :
  1. What is the incidence of epidural blood patches (EBP)? [ Time Frame: 1 year ]
    Looking at the incidence of EBP in the spinal catheter group, in comparison to the resited epidural group.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Obstetrical population

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

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 identifier (NCT number): NCT01448590

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

Responsible Party: Lynn Haslam, Nurse Practitioner, Sunnybrook Health Sciences Centre Identifier: NCT01448590     History of Changes
Other Study ID Numbers: SHSC-Haslam-PDPH
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016

Keywords provided by Lynn Haslam, Sunnybrook Health Sciences Centre:
post dural puncture headache
accidental dural puncture
spinal catheter
epidural catheter
intrathecal catheter
dural puncture
systemic review

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