Ignite Creation Date:
2024-05-05 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00746863
Status:
COMPLETED
Last Update Posted:
2010-06-22
First Post:
2008-09-03
Brief Title:
Randomized Control Trial to Assess Postoperative Pain After Sling Placement
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Injection of 0125 Marcaine During Mid-Urethral Sling Placement for Pain Relief A Randomized Control Trial
Status:
COMPLETED
Status Verified Date:
2010-06
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:
There are many ways to perform a suprapubic approach pubovaginal sling Some surgeons inject local pain medical into the retropubic space before placing the sling others do not This study is to determine if injection of local pain medication into the retropubic space before placing a mid-urethral sling for urinary stress incontinence results in lower postoperative pain scores lower use of postoperative narcotic medication and lower rates of urinary retention
Detailed Description:
To evaluate if an injection in the retropubic space with a local acting anesthetic Marcaine bupivacaine at the time of mid-urethral sling placement will improve patients reported post operative pain and decrease the use of narcotic pain medication This study will include all female patients age 18 and older who will undergo a mid-urethral sling with or without anterior repair for the treatment of urinary stress incontinence by a member of the Division of Urogynecology and Reconstructive Pelvic Surgery who consent to be in the study
Once patients have consented to participate in the study they will be randomized into two groups One group will have the mid-urethral sling placed in the usual fashion with no injection of local anesthetic The other group will have the mid-urethral sling placed after the retropubic space has been infiltrated with local anesthetic as previously described in the literature Pain will be assessed with the use of a Visual Analog Scale during the hospitalization and the use of narcotic pain medication will be assessed during recovery and overnight in the hospital Patients will be asked to record how often and what type of pain medication they use Patients will also be asked to keep a log of their urination if they are discharged home with self catheterization They will be asked to mail in their pain medication log and voiding diary if needed at a two-week post-operative Outcomes will then be compared
Once patients have consented to participate in the study they will be randomized into two groups One group will have the mid-urethral sling placed in the usual fashion with no injection of local anesthetic The other group will have the mid-urethral sling placed after the retropubic space has been infiltrated with local anesthetic as previously described in the literature Pain will be assessed with the use of a Visual Analog Scale during the hospitalization and the use of narcotic pain medication will be assessed during recovery and overnight in the hospital Patients will be asked to record how often and what type of pain medication they use Patients will also be asked to keep a log of their urination if they are discharged home with self catheterization They will be asked to mail in their pain medication log and voiding diary if needed at a two-week post-operative Outcomes will then be compared
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