Pain After Surgery, PSP, Chronic Pain Syndrome, Local Anesthesia Infiltration
Conditions
Keywords
TVT, TVTO, Mid Urethral Sling, pain, chronic pain syndrom
Brief 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.
Interventions
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.
OTHERPlacebo
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.
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity assessed using the Numerical Rating Scale (NRS, 0-10 scale) | Within 24 hours after surgery, at 1 month, and at 6 months postoperatively | 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. |
Contacts
CONTACTNir Cohen, MD-MPh
Outcome results
None listed