Clinical trial NCT00746863: Randomized Control Trial to Assess Postoperative Pain After Sling Placement
Official title: Injection of 0.125% Marcaine During Mid-Urethral Sling Placement for Pain Relief: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: mid-urethral sling
pubovaginal sling
postoperative pain
visual analog scale
suprapubic approach
SPARC sling
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2008-09-04
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Any female patient, age 18 or older, who elects to have a mid-urethral sling with or without an anterior or posterior repair at the University of North Carolina Hospitals by a member of the Division of Urogynecology.

Exclusion Criteria:

* Any patient with a chronic pain syndrome, a contraindication to nonsteroidal anti-inflammatory drugs (NSAIDs) such as liver disease, abnormal coagulation, esophageal disorders or peptic ulcers or where pain evaluation is unreliable because of neurological disease and those on treatment with steroids/NSAIDs/opioids prior to surgery.
* Also excluded will be any patient who is having any other reconstructive pelvic surgery concomitantly or would require the placement of a suprapubic catheter.
* Patients electing to have their surgery with regional anesthesia, such as an epidural or spinal will be excluded.
* All minors, decisional impaired people, nursing mothers and non-English speaking people will be excluded.

Primary outcomes:
measure: Difference in Postoperative Pain Using a Visual Analog Scale at 2 Hours.
timeFrame: 2 hours postoperative from mid-urethral sling placement
measure: Difference in Postoperative Pain Using a Visual Analog Scale at 6 Hours.
timeFrame: 6 hours postoperative from mid-urethral sling placement
measure: Difference in Postoperative Pain Using a Visual Analog Scale at 24 Hours.
timeFrame: 24 hours postoperative from mid-urethral sling placement
Secondary outcomes:
measure: In-hospital Medication Amounts
timeFrame: From surgery until discharge, average
measure: Difference in Successful Voiding Trial Prior to Discharge Following Placement of Mid-urethral Sling Via the Suprapubic Approach.
timeFrame: From after surgery to discharge from hospital.
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Gena C Dunivan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC Chapel Hill
name: Ellen C Wells, MD
role: STUDY_DIRECTOR
References:
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citation: Schatz H, Henriksson L. Pain during the TVT procedure performed under local anesthesia. Int Urogynecol J Pelvic Floor Dysfunct. 2003 Nov;14(5):347-9; discussion 349. doi: 10.1007/s00192-003-1043-6. Epub 2003 Sep 6.
citation: Dogan E, Celiloglu M, Sarihan E, Demir A. Anesthetic effect of intrauterine lidocaine plus naproxen sodium in endometrial biopsy. Obstet Gynecol. 2004 Feb;103(2):347-51. doi: 10.1097/01.AOG.0000109519.74229.30.
citation: Dunivan GC, Parnell BA, Connolly A, Jannelli ML, Horton BJ, Geller EJ. Bupivacaine injection during midurethral sling and postoperative pain: a randomized controlled trial. Int Urogynecol J. 2011 Apr;22(4):433-8. doi: 10.1007/s00192-011-1362-y. Epub 2011 Feb 12.