Clinical trial NCT01448590: Post Dural Puncture Headache After Accidental Dural Puncture
Official title: Systematic Review: Post Dural Puncture Headache After Accidental Dural Puncture: Does Insertion of Spinal Catheter Decrease Incidence of Headaches?
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Post Dural Puncture Headache
Keywords: post dural puncture headache
accidental dural puncture
PDPH
ADP
spinal catheter
epidural catheter
intrathecal catheter
dural puncture
systemic review
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2011-10-07
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obstetrical population

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.

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 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

Primary outcomes:
measure: Number of PDPH after epidural resite versus Number of PDPH after insertion of epidural catheter into spinal space
timeFrame: 1 year
Secondary outcomes:
measure: What is the incidence of epidural blood patches (EBP)?
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Sunnybrook Health Sciences Centre, Toronto
name: Lynn Haslam, RN MN/ACNP
role: PRINCIPAL_INVESTIGATOR
affiliation: Mount Sinai Hospital, Canada
name: Eric Goldszmidt, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: