Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach: Randomized, Double-blind Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- pain after surgery
研究概览
简要总结
The research procedure is the injection of 20 mL of Ropivacaine solution (vs. saline) to create a paracervical block at the beginning of surgery, while the patient is already under general anesthesia.
This injection will take place 3 minutes before the vaginal incision, via 4 injection points. Injections are made 3 mm deep into the vaginal cul de sac.
Randomization takes place before surgery by vNOTES:
- Experienced group: Local anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg/mL, i.e. 150mg) and general anesthesia
- Control group: Injection of 20mL of placebo (saline) and general anesthesia
In both groups, systematic intraoperative and postoperative analgesia will be identical.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 to 70 inclusive
- •Patient scheduled for vNOTES surgery for total hysterectomy for benign pathology, whether or not associated with an adnexal procedure (unilateral or bilateral salpingectomy or adnexectomy (for cysts smaller than 6 cm)).
- •Person having read and understood the information letter and signed the consent form
- •Person affiliated to a social security scheme
排除标准
- •Suspicion of malignant pathology
- •History of rectal surgery
- •History of pelvic inflammatory disease
- •Suspicion of recto-vaginal endometriosis
- •Virginity
- •Contraindication to NAROPEINE 7.5 mg/mL, solution for injection in ampoule
- •Contraindication to PROAMP SODIUM CHLORIDE 0.9%, solution for injection
- •Patients on a low-salt diet
- •History of more than 2 caesarean sections
- •Estimated uterine size > 700 g according to the following formula y = 0.35x + 107 (x = a × b × c), based on measurements taken on preoperative imaging (MRI or ultrasound). a=longitudinal diameter, b=sagital diameter, c=transverse diameter.3
- •BMI > 35
- •Contraindication to analgesic molecules in intraoperative and postoperative protocols.
研究组 & 干预措施
Experienced group
Administration of Naropeine
干预措施: Naropeine (Drug)
Experienced group
Administration of Naropeine
干预措施: questionnaires (Other)
Control group
Administration of a saline solution
干预措施: questionnaires (Other)
Control group
Administration of a saline solution
干预措施: Placebo (Other)
结局指标
主要结局
pain after surgery
时间窗: 4hours after surgery
Pain will be assessed by the post-operative hospital nurse using a numerical rating scale (NRS) NRS score from 1 to 10 -\> 10 correspoding to the worst pain
次要结局
未报告次要终点