Post Dural Puncture Headache After Accidental Dural Puncture
Systematic Review: Post Dural Puncture Headache After Accidental Dural Puncture: Does Insertion of Spinal Catheter Decrease Incidence of Headaches?
1 other identifier
observational
N/A
0 countries
N/A
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.
Trial Health
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Started Jun 2011
Longer than P75 for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 5, 2011
CompletedFirst Posted
Study publicly available on registry
October 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedOctober 13, 2016
October 1, 2016
4.8 years
October 5, 2011
October 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of PDPH after epidural resite versus Number of PDPH after insertion of epidural catheter into spinal space
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.
1 year
Secondary Outcomes (1)
What is the incidence of epidural blood patches (EBP)?
1 year
Study Arms (2)
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
Eligibility Criteria
Obstetrical population
You may qualify if:
- 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
You may not qualify if:
- Any intentional dural punctures (spinal anesthesia) or use of spinal microcatheters were excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lynn Haslam, RN MN/ACNP
Sunnybrook Health Sciences Centre, Toronto
- PRINCIPAL INVESTIGATOR
Eric Goldszmidt, MD FRCPC
Mount Sinai Hospital, Canada
Study Design
- Study Type
- observational
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nurse Practitioner
Study Record Dates
First Submitted
October 5, 2011
First Posted
October 7, 2011
Study Start
June 1, 2011
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
October 13, 2016
Record last verified: 2016-10