A randomized controlled double blind trial comparing effect of different pulmonary recruitment manoeuvre pressures on post-laparoscopic shoulder pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- To compare the effect of two different pulmonary recruitment manoeuvre pressures on intensity of post-laparoscopic shoulder pain
研究概览
简要总结
A prospective randomized double blind trial will be conducted in ASA I and II patient posted for laparoscopic surgeries under general aneaesthesia.
Primary aim is to assess effect of different pulmonary recruitment manoeuvre pressures on post-laparoscopic shoulder pain.
Secondary objectives include monitoring hemodynamic parameters before and after PRM, total consumption of analgesics in 24 hrs in all groups and side effects like nausea and vomiting.
Patients will be divided into 3 groups on the basis of a computer generated randomisation table:
Group 1 - will receive PRM of 20cmH2O in addition to routine method
Group 2- will receive PRM of 40cmH2O in addition to routine method
Group 3 - will receive routine method of removing CO2 by passive exsufflation by applying gentle abdominal pressure by surgeon
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA I and II patients posted for laparoscopic surgeries under GA of duration upto 4 hours.
排除标准
- •Patient refusal to participate in study, BMI more than 30, patients with chronic shoulder pain, history of previous shoulder surgery, COPD/respiratory pathologies, patients with hemodynamic instability, high intracranial pressure and right heart failure, pregnancy.
结局指标
主要结局
To compare the effect of two different pulmonary recruitment manoeuvre pressures on intensity of post-laparoscopic shoulder pain
时间窗: post operative hemodynamic assessment at 1 min, 3min and 5 mins after the maneouvre is performed, followed by vas score, total analgesia consumption and side effect assessment postoperatively upto 24 hours (every 2 hours for first 12 hours, every 6 hours for next 12 hours)
次要结局
- side effects like nausea and vomiting(post-operatively upto 24 hours)
- Hemodynamic parameters before and after PRM(Intra-operatively before PRM and 1,3 and 5 mins after PRM)
- Total consumption of analgesics in 24 hours in all groups(post-operatively upto 24 hours)
研究者
Dr Nithu Dina Joseph
Bharati Vidyapeeth Deemed to be University