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临床试验/NCT04609033
NCT04609033已完成不适用

Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy

Assiut University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2020年10月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
postoperative level of ACTH hormone

研究概览

简要总结

Postoperative abdominal and shoulder pain that are experienced in patients undergoing laparoscopic cholecystectomy (LC) is significant. Although it is generally less sever than post open cholecystectomy pain, it still causes an avoidable distress in the first 24 hours postoperatively

详细描述

The incidence of pain after laparoscopy may be as high as 36 to 63 percent and is attributed to the carbon dioxide gas (CO2) used to induce pneumo-peritoneum1.

The residual part of CO2 remains in the peritoneal cavity for several days after the operation and causes stretching of the phrenic nerve endings, local hypothermia, and diaphragmatic irritation by carbonic acid formation

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for Laparoscopic cholecystectomy.
  • Age spectrum of 18 - 55 years
  • ASA I, II
  • Have no comorbid chronic medical diseases

排除标准

  • Patients with co morbid medical diseases
  • Age outside the specified range
  • Acute inflammation of the gall bladder
  • Critically ill patient
  • Emergency operations
  • Patient refusal

研究组 & 干预措施

bupivacaine group

Active Comparator

干预措施: Bupivacaine (Drug)

bupivacaine + morphine

Active Comparator

干预措施: Bupivacaine + morphine (Drug)

bupivacaine + morphine + ketamine

Active Comparator

干预措施: Bupivacaine + morphine + ketamine (Drug)

isotonic saline

Placebo Comparator

干预措施: isotonic saline (Drug)

结局指标

主要结局

postoperative level of ACTH hormone

时间窗: 6 hours

a stress marker that increase with pain and surgery

次要结局

  • VISUUEAL ANALOGE SCORE(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Esam Hamed

consultant

Assiut University

研究点 (1)

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