NCT07429019

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

Reduction of Post-surgery Pelvic Pain by Bupivacaine Injection During TVT/ TVT-O Procedure

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain After Surgery
• PSP
• Chronic Pain Syndrome
• Local Anesthesia Infiltration

Interventions

Type	Name	Description
DRUG	Bupivacain (Postoperative)	A 5 mL injection of 0.5% bupivacaine will be administered into the trans-obturator/levator ani sling insertion site at the end of the TVT or TVT-O procedure, prior to wound closure.
OTHER	Placebo	Participants will receive a 5 mL injection of sterile 0.9% normal saline into the trans-obturator/levator ani sling insertion site at the end of the TVT or TVT-O procedure, prior to wound closure.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2026-02-24
• Last updated: 2026-02-24