跳至主要内容
临床试验/CTRI/2020/08/027342
CTRI/2020/08/027342尚未招募Phase 3 4

To compare the efficacy of intraperitoneal instillation of ropivacaine and butorphanol versus ropivacaine and nalbuphine for post-operative pain relief in patients undergoing laparoscopic cholecystectomy under general anaesthesia

NA1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年8月25日最近更新:
适应症

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
To compare the efficacy of intraperitoneal instillation of ropivacaine and butorphanol versus ropivacaine and nalbuphine for post-operative pain relief in patients undergoing laparoscopic cholecystectomy under general anaesthesia.

研究概览

简要总结

Post-operativepain after laparoscopic cholecystectomy is avery common complication hinderingearly return of routine activity. In various studies intraperitonealinstillation of local anaesthetics have been shown to be safe, effective andminimally invasive and opioids have shown to have a synergestic effect.Ropivacaine is shown to be more safe and efficacious as compared to other localanaesthetics such as bupivacaine. Similarly, nalbuphine is better than otheropioids due to its mixed action on opioid receptors. Since agonist opioids arenot available with us, the most common drug used for intraoperative analgesiais IV butorphanol. So the purpose of our study is to compare the effect of intraperitonealbutorphanol with intraperitoneal nalbuphine for laparoscopic cholecystectomy.

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

  • •1.ASA physical status I and II.
  • •2.Elective laparoscopic cholecystectomy.

排除标准

  • •1.Acute cholecystitis.
  • •2.Carcinoma Gall bladder.
  • •3.Hypersensitivity to study drugs.
  • •4.Pregnant females.
  • •5.Bleeding disorders.
  • •6.Opioid addicts.
  • •7.Patient refusal to participate in the study.

结局指标

主要结局

To compare the efficacy of intraperitoneal instillation of ropivacaine and butorphanol versus ropivacaine and nalbuphine for post-operative pain relief in patients undergoing laparoscopic cholecystectomy under general anaesthesia.

时间窗: After extubation of patient till 24 hours.

次要结局

  • To compare the timing of first request and frequency of rescue analgesia.(After extubation of patient till 24 hours.)

研究者

发起方
NA
申办方类型
Other []

研究点 (1)

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