Reduction of Post-surgery Pelvic Pain by Bupivacaine Injection During TVT/ TVT-O Procedure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Postoperative pain intensity assessed using the Numerical Rating Scale (NRS, 0-10 scale)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Bupivacaine surgical site injection
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.
干预措施: Bupivacain (Postoperative) (Drug)
Placebo: Saline Injection
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.
干预措施: Placebo (Other)
结局指标
主要结局
Postoperative pain intensity assessed using the Numerical Rating Scale (NRS, 0-10 scale)
时间窗: 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.
次要结局
未报告次要终点