Effect of Intraperitoneal Instillation of Ropivacaine on Perioperative Peak Expiratory Flow Rate (PEFR) in Patients Undergoing Elective Laparoscopic Cholecystectomy under General Anaesthesia – A randomized, prospective, double blind study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare perioperative PEFR in patients undergoing laparoscopic cholecystectomy under general anaesthesia with and without intraperitoneal instillation of 20 ml of 0.5% Ropivacaine.
研究概览
简要总结
BACKGROUND OF STUDY
Laparoscopic cholecystectomy – gold standard for gall bladder removal surgeries
Pneumo-peritoneum induced diaphragmatic paresis and irritation results in postoperative pulmonary dysfunction-mainly the inability to produce adequate cough
PEFR was the good spirometric test to predict postoperative complications - reflects the ability to produce an adequate cough
Adequate post-operative analgesia – important for early return of pulmonary function to baseline level.
Traditional methods like NSAIDs, narcotics and periportal local anaesthetic infiltration have no effect on this diaphragmatic irritation
RESEARCH QUESTION
Does intraperitoneal instillation of Ropivacaine augment faster return to baseline PEFR in patients undergoing elective laparoscopic cholecystectomy under general anaesthesia?
OBJECTIVES
Primary - To compare perioperative PEFR in patients undergoing laparoscopic cholecystectomy under general anaesthesia with and without intraperitoneal instillation of 20 ml of 0.5% Ropivacaine.
Secondary - To find the time to first rescue analgesic in both groups.
METHODOLOGY
All patients will receive intravenous Dexamethasone 1 mg/kg and intravenous Ondansetron 0.15 mg/kg after excision of gall bladder
All patients will receive intravenous Diclofenac 75 mg and intravenous Paracetamol 1 gm at start of port closure
Group R patients will receive 20 ml 0.5 % Ropivacaine intraperitoneally in the Gall Bladder Fossa prior to port closure
Group S patients will receive 20 ml of Normal Saline intraperitoneally in the Gall Bladder Fossa prior to port closure
Deflation of pneumoperitoneum will be done prior to port closure
Patients will be extubated using Myopyrrolate, as per body weight, and when Train-of-Four Ratio of ≥ 0.9 is achieved
Rescue analgesic : Inj. Fentanyl 1 µ/kg if NRS ≥ 4. Time to 1st Rescue analgesic will be noted.
Intraoperative Monitoring (5 mints)
Heart rate, Blood pressure – SPB, DBP, MAP, SpO2,End tidal CO2,NM monitoring,Intra-abdominal pressure,Number of intubation attempts,Airway pressures,Analgesics used,Duration of surgery
Postoperative Monitoring (5 mints)
Heart rate, Blood pressure – SBP, DBP, MAP
SpO2, Pain score ( NRS ),Time to 1st rescue analgesic, Rescue analgesics used,Ramsay Sedation Score. PEFR at 2 h, 6 h, 12 h, 24h.
Incentive spirometry value
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient undergoing Elective laparoscopic cholecystectomy.
排除标准
- •Patient having OSA.
- •Patient having cardiopulmonary functional limitation patient having psychiatric illness.
- •Emergency surgery surgical duration less than 1hour & more than 3hours patient with BMI of more than 30 kg/m2.
结局指标
主要结局
To compare perioperative PEFR in patients undergoing laparoscopic cholecystectomy under general anaesthesia with and without intraperitoneal instillation of 20 ml of 0.5% Ropivacaine.
时间窗: at 2hour , 6 hour , 12 hour , 24 hour
次要结局
- To find the time to first rescue analgesic in both groups.
研究者
Mansha shaharyar
Tata Main Hospital Jamshedpur Jharkhand
