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临床试验/CTRI/2024/06/068315
CTRI/2024/06/068315尚未招募2 期

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

Tata main hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年6月20日最近更新:

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

申办方类型
Other [Industrial hospital]
责任方
Principal Investigator
主要研究者

Mansha shaharyar

Tata Main Hospital Jamshedpur Jharkhand

研究点 (1)

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