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

N/ANot Yet RecruitingNCT07429019

Hadassah Medical Organization60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Pain After Surgery PSP Chronic Pain Syndrome

Interventions

Bupivacain (Postoperative)DRUG

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.

PlaceboOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * Planned concomitant abdominal, laparoscopic, or robotic surgery * Pre-existing chronic pelvic pain * Diagnosis of fibromyalgia * Diagnosis of endometriosis * Inability to complete follow-up assessments * Inability to provide informed consent

Outcomes

Primary Outcomes

Postoperative pain intensity assessed using the Numerical Rating Scale (NRS, 0-10 scale)

Pain intensity will be evaluated using the 11-point Numerical Rating Scale (NRS), where 0 represents no pain and 10 represents the worst pain imaginable. Assessments will be performed during hospital recovery (within 12-24 hours after surgery), at 1 month, and at 6 months postoperatively to evaluate both acute and chronic postsurgical pain.

Time frame: Within 24 hours after surgery, at 1 month, and at 6 months postoperatively