An interventional study of Bupivacain (Postoperative) and Placebo in Pain After Surgery, PSP and Chronic Pain Syndrome, sponsored by Hadassah Medical Organization. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
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)
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
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.
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.
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.
Time frame: Within 24 hours after surgery, at 1 month, and at 6 months postoperatively
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Hadassah Medical Organization