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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nir Cohen, MD-MPh | Contact | 00972506716211 | nirco@hadassah.org.il |
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| 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. |
|
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011184 | Postoperative Period |
| ID | Term |
|---|---|
| D059035 | Perioperative Period |
| D013514 | Surgical Procedures, Operative |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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