A Prospective Randomized Double-Blind Placebo-Controlled Trial Evaluating the Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Postoperative Pain Score at 6 Hours
研究概览
简要总结
This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of paracervical block on early postoperative pain after vaginal natural orifice transluminal endoscopic surgery (vNOTES) uterosacral ligament suspension.
Eligible patients undergoing vNOTES uterosacral ligament suspension for benign gynecologic indications will be randomly assigned in a 1:1 ratio to receive either 10 mL of 0.5% bupivacaine or 10 mL of normal saline as a paracervical injection during surgery.
The primary outcome is postoperative pain assessed using the Visual Analog Scale (VAS) at 6 hours after surgery. Secondary outcomes include pain scores at multiple time points within 24 hours, total analgesic consumption, length of hospital stay, and patient satisfaction.
The study aims to determine whether paracervical block provides clinically meaningful pain reduction in the early postoperative period following vNOTES procedures.
详细描述
Postoperative pain management remains an important component of enhanced recovery protocols in minimally invasive gynecologic surgery. Although vNOTES uterosacral ligament suspension is associated with reduced abdominal wall trauma, patients may still experience significant early postoperative pelvic pain. Paracervical block with local anesthetic agents has been proposed as a potential strategy to reduce early postoperative pain; however, high-quality randomized evidence in the context of vNOTES procedures is limited.
This single-center, prospective, randomized, double-blind, placebo-controlled trial will enroll 58 patients undergoing vNOTES uterosacral ligament suspension. Participants will be randomized using computer-generated permuted block randomization with allocation concealment ensured through sequentially numbered, opaque, sealed envelopes. During surgery, a blinded syringe containing either 0.5% bupivacaine or normal saline will be prepared by independent personnel and administered as a paracervical injection.
Postoperative pain will be evaluated using the Visual Analog Scale (VAS) at predefined time points (0, 1, 2, 4, 6, 12, and 24 hours). The primary endpoint is VAS score at 6 hours postoperatively. Secondary endpoints include total analgesic consumption within 24 hours, patient satisfaction, and perioperative recovery parameters. Statistical analyses will be conducted according to the intention-to-treat principle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, care providers, investigators, and outcome assessors will be blinded to group allocation. Study solutions (0.5% bupivacaine or normal saline) will be prepared in identical syringes by independent personnel not involved in postoperative assessment. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes.
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
- •Female patients aged 18 years or older
- •Symptomatic pelvic organ prolapse requiring uterosacral ligament suspension (USLS)
- •Planned hysterectomy (vaginal hysterectomy or vNOTES hysterectomy) with concomitant BS or BSO, followed by vNOTES uterosacral ligament suspension
- •ASA physical status I-III
- •Ability to provide written informed consent
排除标准
- •Known allergy or hypersensitivity to bupivacaine or local anesthetic agents
- •Chronic opioid use or chronic pain disorders
- •Previous pelvic radiation therapy
- •Severe hepatic or renal impairment
- •Coagulopathy or anticoagulant therapy contraindicating injection
- •Active pelvic infection
- •Pregnancy
- •Inability to understand the pain scoring system
研究组 & 干预措施
Paracervical Block (Bupivacaine)
Participants will receive 10 mL of 0.5% bupivacaine administered as a paraservical injection during vNOTES uterosacral ligament suspension.
干预措施: Bupivacaine (Drug)
Placebo (Normal Saline)
Participants will receive 10 mL of 0.9% normal saline administered as a paraservical injection during vNOTES uterosacral ligament suspension.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Postoperative Pain Score at 6 Hours
时间窗: 6 hours after completion of surgery (assessed once at postoperative hour 6)
Postoperative pain intensity assessed using a 10-cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores represent greater pain intensity.
次要结局
- Postoperative Pain Scores Within 24 Hours(From completion of surgery through postoperative hour 24 (assessed at 0, 1, 2, 4, 12, and 24 hours))
- Total Analgesic Consumption(From completion of surgery through postoperative hour 24 (cumulative dose assessed up to 24 hours))
- Patient Satisfaction(24 hours after completion of surgery (assessed once at postoperative hour 24))
- Length of Hospital Stay(From the date of surgery until hospital discharge, assessed up to 30 days postoperatively)
研究者
Erkan Gol
Principal Investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital