Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04696627
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2021-01-04
Brief Title:
Long-term Complications of Unintentional Dural Puncture During Labour Epidurals and Epidural Blood Patch
Sponsor:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Organization:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Study Overview
Official Title:
Long-term Complications of Unintentional Dural Puncture During Labour Epidurals and Epidural Blood Patch
Status:
COMPLETED
Status Verified Date:
2021-02
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 investigators plan to evaluate long-term consequences of unintentional dural puncture in women who had this complication during labor epidural insertion at Mount Sinai Hospital A dural puncture is the perforation of the dura mater one of the layers protecting the brain and the spinal cord by the needle that is used to find and place a catheter in the epidural space A puncture will cause a leakage of cerebrospinal fluid through the dura that results in an acute and usually self-limited headache in half of patients who have this complication The usual treatment for this complication is conservative with the use of oral medications like acetaminophen anti-inflammatory and narcotics In the severely symptomatic patient the injection of blood in the epidural space is a more invasive approach performed to patch the hole that was created in the dura epidural blood patch The objective is to determine whether or not there is a risk of developing long-term effects from the unintentional dural puncture and its treatment by epidural blood patch by comparing women who had a dural puncture during their labour epidural insertion with or without an epidural blood patch with women who received an epidural but did not have a dural puncture during the same period of time
The hypothesis is that women who had unintentional dural punctures during epidural insertion will develop long-term effects such as chronic headache chronic backache chronic auditory or visual disturbances and chronic disability more frequently than women who received an epidural but did not sustain a dural puncture The investigators also hypothesize that the use of epidural blood patch may change the course of these complications
The hypothesis is that women who had unintentional dural punctures during epidural insertion will develop long-term effects such as chronic headache chronic backache chronic auditory or visual disturbances and chronic disability more frequently than women who received an epidural but did not sustain a dural puncture The investigators also hypothesize that the use of epidural blood patch may change the course of these complications
Detailed Description:
The investigators will study women who have sustained an unintentional dural puncture at least one year prior to the start date of the study and the investigators will study cases occurring during a period of 5 years These women will be matched by type of procedure labor epidural month of delivery and age with women who have received an epidural but did not sustain an unintentional dural puncture The group of women who sustained dural punctures will be further divided into two groups whether they have received epidural blood patch or not to study the influence of the epidural blood patch on the outcomes Women will have their anesthetic records reviewed to collect data on the anesthetic technique presence of a dural puncture and treatment if applicable All patients who qualify will be contacted and invited to take part in this study Those consenting to the study will be interviewed by phone or answer the survey electronically During the interview they will answer questions derived from validated questionnaires for the majority of our outcomes of interest In the few outcomes where a validated questionnaire does not exist the investigators will search for our endpoint with dichotomic yesno questions The investigators will then compare the data gathered in the three different groups to validate or invalidate our hypothesis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None