Intraoperative Bupivacaine Injection to Reduce Acute and Chronic Pain After TVT/TVT-O Surgery. Randomized Double-Blind Trial
Not yet recruitingNot applicableNCT07429019
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Reduction of Post-surgery Pelvic Pain by Bupivacaine Injection During TVT/ TVT-O Procedure
- Conditions
- Pain After Surgery
- PSP
- Chronic Pain Syndrome
- Local Anesthesia Infiltration
- Interventions
- Drug: Bupivacain (Postoperative)
- Other: Placebo
- Sponsor
- Hadassah Medical Organization
- Start date
- 2026-07-01
- Primary completion
- 2027-07-01
- Sex
- Female
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07429019