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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Pain After Surgery Chronic Pain Syndrome Local Anesthesia Infiltration Neurologic Manifestations PSP Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo

Other

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.

Primary outcomes

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

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

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nir Cohen, MD-MPh

CONTACT

[email protected]

00972506716211

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

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

Acronym: PAIN-TVT

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Feb 24, 2026
Registry last updated: Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting