Intraoperative Bupivacaine Injection to Reduce Acute and Chronic Pain After TVT/TVT-O Surgery. Randomized Double-Blind Trial
Starting soon · Not applicable · Has a placebo group
Conditions studied: Pain After Surgery, PSP, Chronic Pain Syndrome, Local Anesthesia Infiltration
In brief
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.
Key facts
- Study ID
- NCT07429019
- Run by
- Hadassah Medical Organization
- People needed
- 60
- Starts
- 2026-07-01
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2026-06-23
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
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
Full record on ClinicalTrials.gov
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