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NCT07429019
Intraoperative Bupivacaine Injection to Reduce Acute and Chronic Pain After TVT/TVT-O Surgery. Randomized Double-Blind Trial
Conditions: Pain After Surgery, PSP, Chronic Pain Syndrome, Local Anesthesia Infiltration
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Hadassah Medical Organization
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.
Eligibility Criteria
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 (NCT07429019). StuddyBuddy aggregates publicly available trial information.