About this trial
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.
Eligibility criteria
Qualifiers
Women aged 18 years or older
Scheduled to undergo vaginal surgery including TVT or TVT-O procedure for stress urinary incontinence
Able and willing to provide written informed consent
Willing to complete postoperative follow-up assessments for at least 6 months
Disqualifiers
Planned concomitant abdominal, laparoscopic, or robotic surgery
Pre-existing chronic pelvic pain
Diagnosis of fibromyalgia
Diagnosis of endometriosis
Trial design
Treatments tested in this trial
- Bupivacain (Postoperative)
- Placebo
Treatment groups
Locations
Sponsors and collaborators
Hadassah Medical Organization
Lead sponsor