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临床试验/CTRI/2023/01/048937
CTRI/2023/01/048937尚未招募不适用

Evaluation of post operative analgesic effects of intraperitoneal instillation of bupivacaine with morphine and bupivacaine buprenorphine for laparoscopic cholecystectomy : A double blind comparative study

Dr Ramesh Kumar PB1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To assess analgesic effects

研究概览

简要总结

This is a Randomized, Double-Blinded study to asess, compare and evaluate post operative analgesic effects of intraperitoneal instillation of 25ml 0.25% bupivacaine and 2mg morphine versus 25ml 0.25% bupivacaine and 0.3mg buprenorphine to provide effective post operative pain relief in patients undergoing laparoscopic cholecystectomy under general anesthesia. Pre anaesthetic examination will be done and standard NPO guidelines will be followed. Premedication inj.pantoprazole 40mg intravenous, inj.ondansteron 4mg intravenous will be given Patients aged between 18year and 60year belonging to American Society of Anaesthesiology (ASA) I and II were randomized into two groups i.e BM and BB group BM group will be receiving intraperitoneal instillation of 25ml 0.25%bupivacaine and 2mg morphine and BB group will be receiving intraperitoneal instillation of 25ml 0.25%bupivacaine and 0.3mg buprenorphine and these medications will be given after peritoneal wash and suctioning through intraperitoneal instillation .The drug solution will be prepared by doctor who does not participate in the study. All patients will receive same anaesthesia method in each group. Patients in each group will be monitored for electrocardiogram(ECG),heart rate ,oxygen saturation (SpO2 saturation) and non invasive blood pressure(NIBP), end tidal carbon dioxide(EtCO2) Post operative pain will be evaluated using Visual Analog scale (pain score 0 -10) and verbal rating scale(VRS) for 24hrs after surgery .The post operative pain outcome will be reported at 0 and 30min 1,4,8,12,16,24hr. The cut off value for VAS is 4 for indication of rescue analgesic . At VAS>= 4 ,rescue analgesics will be administered on request, inj. diclofenac sodium75mg intravenously post operatively.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
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

  • Patients willing to give written informed consent.
  • ASA physical status I and II patients.
  • Patients undergoing elective laparoscopic surgeries.

排除标准

  • Patients having a known allergy to the study drug.

结局指标

主要结局

To assess analgesic effects

时间窗: Pain Assessment will be done at 0 minutes,30 minutes, 1 hour, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours

次要结局

  • Overall Safety of drugs(0 minutes,30 minutes, 1 hour, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours)

研究者

发起方
Dr Ramesh Kumar PB
申办方类型
Other [self]

研究点 (1)

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