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

NCT07429019 | Not Yet Recruiting DMC

• 1 other identifier: HMO-0550-25
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

TVT; TVTO; Mid Urethral Sling; pain; chronic pain syndrom

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Bupivacaine surgical site injection

ACTIVE COMPARATOR

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)

Placebo: Saline Injection

PLACEBO COMPARATOR

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

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.

Bupivacaine surgical site injection

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.

Placebo: Saline Injection

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

MeSH Terms

Conditions

Pain

Interventions

Postoperative Period

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Nir Cohen, MD-MPh

CONTACT

00972506716211; nirco@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2026
• First Posted: February 24, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share