drugset / Trial / NCT07429019

Intraoperative Bupivacaine Injection to Reduce Acute and Chronic Pain After TVT/TVT-O Surgery. Randomized Double-Blind Trial

NCT07429019

Not yet recruiting 60 enrolled Hadassah Medical Organization
RandomizedParallel-groupTriple-blindPrevention

Summary

This randomized, double-blind controlled trial will evaluate whether intraoperative injection of bupivacaine at the sling insertion site reduces postoperative pelvic and thigh pain in women undergoing TVT or TVT-O surgery for stress urinary incontinence. Women aged 18 years and older scheduled for vaginal surgery including a mid-urethral sling procedure will be randomly assigned to receive either 0.5% bupivacaine or saline injection at the surgical site at the end of the procedure. Postoperative pain will be assessed using the Numerical Rating Scale (NRS) within 24 hours after surgery, at one month, and at least six months postoperatively. The study will also evaluate opioid consumption and examine the relationship between early postoperative pain and the development of chronic postsurgical pain. The results may help determine whether local anesthetic injection during sling surgery can improve short- and long-term pain outcomes.

Timeline

Start
2026-07-01
Primary completion
2027-07-01
Completion
2027-10-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 0.5 % Other
Comparator Bupivacaine Other / unclassified 5 ml Other

Indications