Randomized Study Comparing the Combination Intraperitoneal Local Anesthetics, Maneuvers Alveolar Recruitment and Abdominal Compression Compared to Passive Exsufflation of the Pneumoperitoneum in the Prevention of Pain Shoulders After Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Shoulder pain at rest assessed by visual analog scale
研究概览
简要总结
The purpose of this study is to assess shoulder pain at rest (average over the last 24 hours) assessed by visual analogue scale from 0 to 100mm on Day 1.
详细描述
This is an interventional, comparative, controlled, randomized, single-blind study (the patient will be blinded to the result of the randomization, unlike the investigator) and single-center.
Comparative prospective cohort study of laparoscopic surgery with the addition of specific non-surgical interventions aimed at preventing postoperative shoulder pain (use of local intraperitoneal anesthetics, alveolar recruitment maneuver and compression maneuver abdominal) versus without specific interventions aimed at preventing post-operative shoulder pain.
All patients will benefit from Transversus Abdominis Plane block with multimodal analgesia provided in the usual setting of laparoscopic surgery.
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
- Single (Participant)
盲法说明
The patient will be blinded to the result of the randomization, unlike the investigator.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Celiosurgery including a Transversus Abdominis Plane block with multimodal analgesia;
- •Planned laparoscopic surgery for gallbladder, inguinal hernia, umbilical hernia, incisional hernia repair, adnexectomy, oophorectomy, endometriosis, tube ligation;
- •Affiliation to the social security scheme;
- •Signed informed consent
排除标准
- •Celiosurgery such as colectomy, bariatric surgery, hysterectomy, prostatectomy, nephrectomy;
- •Surgical emergency;
- •History of chronic obstructive pulmonary disease;
- •Weight less than 50 kg;
- •Consumption of preoperative opioids;
- •Antidepressant treatment and/or anxiolytic treatment;
- •Conversion by laparotomy;
- •Intraperitoneal sepsis;
- •Major intraoperative complication (hemorrhage, anaphylaxis, etc.);
- •Other surgical or medical interventions planned during the study;
- •Patient participating in another clinical trial, or during a period of exclusion from another clinical trial;
- •Inability to understand information related to the study;
- •Woman who is pregnant or likely to be pregnant (of childbearing age, without effective contraception) or currently breastfeeding;
- •Patient deprived of liberty or under guardianship or curatorship or unable to give consent.
结局指标
主要结局
Shoulder pain at rest assessed by visual analog scale
时间窗: 1 day
Shoulder pain at rest (average over the last 24 hours) assessed by visual analog scale from 0 to 100mm. ANCOVA (Analysis of Covariance) analysis will be applied to compare the mean shoulder pain visual analog scal (0 to 100 mm) between the groups, adjusted to the baseline value.
次要结局
未报告次要终点