Post Dural Puncture Headache After Accidental Dural Puncture

NCT ID: NCT01448590

Last Updated: 2016-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Post Dural Puncture Headache

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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Epidural Resite

After ADP, those patients who receive an epidural resite.

No interventions assigned to this group

Spinal catheter

After ADP, those who receive the epidural catheter into the spinal space

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Lynn Haslam

Nurse Practitioner

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lynn Haslam, RN MN/ACNP

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre, Toronto

Eric Goldszmidt, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Hospital, Canada

Other Identifiers

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SHSC-Haslam-PDPH

Identifier Type: -

Identifier Source: org_study_id

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