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

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Hadassah Medical Organization

Lead sponsor