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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain Syndrome; PSP; Local Anesthesia Infiltration; Pain After Surgery
• Intervention / Treatment: Drug: Bupivacain (Postoperative); Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nir Cohen, MD-MPh; Phone Number: 00972506716211; Email: nirco@hadassah.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bupivacaine surgical site injection; Participants undergoing TVT or TVT-O surgery for stress urinary incontinence will receive a 5 mL injection of 0.5% bupivacaine into the trans-obturator/levator ani muscle sling insertion site at the end of the procedure. All participants will receive standard postoperative care, including systemic analgesics as needed.	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.
Placebo Comparator: Placebo: Saline Injection; Participants undergoing TVT or TVT-O surgery for stress urinary incontinence will receive a 5 mL injection of normal saline into the same surgical site at the end of the procedure. All participants will receive standard postoperative care, including systemic analgesics as needed.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 24 hours after surgery, at 1 month, and at 6 months postoperatively

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 15, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: pain; TVT; TVTO; Mid Urethral Sling; chronic pain syndrom
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services; Perioperative Period; Postoperative Period
• Other Study ID Numbers: HMO-0550-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No