Low-pressure Pulmonary Recruitment Maneuver to Decrease Post-laparoscopic Shoulder Pain in Gynecologic Surgery: A Double-blind Randomized Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- shoulder pain from using PRM 30 cmH2O
研究概览
简要总结
Research objective to compare outcomes (shoulder pain score, wound pain score, post-operative residual pneumoperitoneum, lung complication, GI discomfort, administered additional analgesics, time to hospital staying) of using Pulmonary Recruitment maneuver with pressure 30 cmH2O, 40 cm H2O and control group in women with post laparoscopic gynecologic surgery in Rajavithi hospital.
详细描述
Research design is Randomized control trial. The women who go to laparoscopic gynecologic surgery don't know the allocation. Women will be randomizes in to 3 group: PRM 30 cmH2O, 40 cmH2O and control
After laparoscopic surgery has finished in operator room (before moving off trocar), woman all group will be set in Trenderlenberg position (Tilted head low) and then surgeon will compress abdomen to release residual gas after operation about 2 minutes.
The patients in group of using Pulmonary Recruitment Maneuver will be received positive pressure from balloon bag from anesthesiologist 5 times of setting pressure [30 cmH2O, 40 cmH2O], 5 seconds per time to increase indirect abdominal pressure to release residual gas
After surgery at 12, 24 and 48 hours, patients will be follow up and evaluate shoulder and wound pain. Chest X-ray will be done to evaluate residual pneumoperitoneum and lung complication. GI discomfort, administered additional analgesics and time to hospital staying will be evaluated and recorded.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •Anesthesiologists physical status (ASAPS) classification I-II
- •Absence of Pregnancy
- •With inform-consent
排除标准
- •Inability to accurately express pain
- •Past history of shoulder or lung surgery
- •Chronic shoulder problem
- •Epigastric pain
- •Lung disease such as emphysema or pneumothorax
- •Severe kidney or liver disease
- •Drug allergy (NSAIDs, Paracetamol)
- •On current medication: corticosteroid
- •Psychiatric disorder
结局指标
主要结局
shoulder pain from using PRM 30 cmH2O
时间窗: During stay in hospital around 2-3 days
To compare shoulder pain score(Visual analogue scale from score 0(no pain) to score 10 (maximum pain)) after laparoscopic gynecologic surgery between PRM at 30 cmH2O group and control group at 12, 24 and 48 hrs.
次要结局
- shoulder pain from using PRM 40 cmH2O(During stay in hospital around 2-3 days)
- Post-operative residue pneumoperitoneum(after surgery in day 1)
- Lung complication(after surgery in day 1)
- wound pain(During stay in hospital around 2-3 days)
- GI discomfort(during stay in hospital around 2-3 days)
- Time to hospital staying(During stay in hospital around 2-3 days)
- Administered additional analgesics(During stay in hospital around 2-3 days)