Intraoperative Bupivacaine Injection to Reduce Acute and Chronic Pain After TVT/TVT-O Surgery. Randomized Double-Blind Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bupivacain (Postoperative), Placebo.
- Who it may be relevant to
- Registry conditions: Pain After Surgery, PSP, Chronic Pain Syndrome, Local Anesthesia Infiltration. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Reduction of Post-surgery Pelvic Pain by Bupivacaine Injection During TVT/ TVT-O Procedure
Overview
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
- Drug Bupivacain (Postoperative)
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. - Other Placebo
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.
Primary outcome measures
- Postoperative pain intensity assessed using the Numerical Rating Scale (NRS, 0-10 scale) [Time frame: Within 24 hours after surgery, at 1 month, and at 6 months postoperatively]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07429019 · HMO-0550-25