N/A
N=42
Randomized Control Trial to Assess Postoperative Pain After Sling Placement
Stress Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT00746863 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jun 2010
Primary outcome: Primary: Difference in Postoperative Pain Using a Visual Analog Scale at 2 Hours. — 1.9; 2.6 cm — p=0.0251
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 0.125% Marcaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Postoperative Pain Using a Visual Analog Scale at 2 Hours. |
1.9; 2.6 | 0.0251 sig |
| PRIMARY Difference in Postoperative Pain Using a Visual Analog Scale at 6 Hours. |
2.1; 2.3 | 0.258 |
| PRIMARY Difference in Postoperative Pain Using a Visual Analog Scale at 24 Hours. |
2.0; 2.3 | 0.435 |
| SECONDARY In-hospital Medication Amounts |
4; 6 | 0.0923 |
| SECONDARY Difference in Successful Voiding Trial Prior to Discharge Following Placement of Mid-urethral Sling Via the Suprapubic Approach. |
4; 7 | 0.4756 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00746863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.