Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370604
Status:
COMPLETED
Last Update Posted:
2022-06-09
First Post:
2006-08-29
Brief Title:
Effect of Small Versus Large Epidural Needles on Postdural Puncture Headache Study
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Randomized Controlled Trial Examining the Effect of Small Versus Large Tuohy-type Epidural Needles on the Incidence and Severity of Postdural Puncture Headache
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effect of 19g versus 18g traditional Tuohy-type epidural needles on the incidence and severity of postdural puncture headache PDPH
Detailed Description:
A headache is the most significant complication of dural puncture during epidural placement This complication leads to longer hospital stays and many repeated visits to hospital for management Women suffering from severe postdural puncture headache PDPH are often bedridden and unable to care for themselves or their babiesThe efficacy of epidural blood patch as a gold standard therapy is over-estimated by the earlier poor quality studies The prevalence of dural puncture during epidural anesthesia using current techniques ranges from 003 to 6 in the literature Of these patients 70 to 80 will suffer from moderate to severe PDPH Avoidance of dural puncture is always the goal However complete avoidance is unlikely using current techniques of needle placement This study proposes another method of prevention ie reducing the gauge of the epidural needles if it is shown to be suitable for continuous infusion in adults Most of the risk factors for developing PDPH cannot be changed eg younger age female sex low body mass index history of migraines However epidural needle gauge is a modifiable risk factor Evidence suggests that the use of smaller gauge epidural needles like spinal needles have the potential to reduce the incidence and severity of PDPH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None