Post Dural Puncture Headache After Accidental Dural Puncture

Post Dural Puncture Headache Clinical Trial

Official title:

Systematic Review: Post Dural Puncture Headache After Accidental Dural Puncture: Does Insertion of Spinal Catheter Decrease Incidence of Headaches?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01448590
• Other study ID #: SHSC-Haslam-PDPH
• Status: Withdrawn
• Phase: N/A
• First received: October 5, 2011
• Last updated: October 12, 2016
• Start date: June 2011
• Est. completion date: March 2016

Study information

• Verified date: October 2016
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Headache
• Post Dural Puncture Headache
• Post-Dural Puncture Headache
• Wounds and Injuries

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	What is the incidence of epidural blood patches (EBP)?	Looking at the incidence of EBP in the spinal catheter group, in comparison to the resited epidural group.	1 year	No