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临床试验/NCT04964180
NCT04964180已完成不适用

Rectal Indomethacin Versus Intraperitoneal Lidocaine for Analgesia After Laparoscopic Cholecystectomy

South Valley University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年5月1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
80
试验地点
1
主要终点
VAS scores postoperative

研究概览

简要总结

Hospitals, Qena, Egypt in period between May 2020 to May 2021.eighty patients was scheduled to elective laparoscopic cholecystectomy , divided Into two groups randomly using closed envelop method. Group IP lidocaine(40 patients ) received 200 ml saline containing 200 mg 2%lidocaine immediately after abdominal cO2 insufflation( pneumoperitoneum) the surgeon sprayed the total solution on the upper surface of the liver under the right subdiaphragmatic space, left subdiaphragmatic space and around the cholecystectomy site , all patients were maintained in trendelenberg position.

At the end of the laparoscopic procedure, group indomethacin (40 patients) recived two 100 mg indomethacin rectal suppositories 2 hours prior to surgery

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • .ASA physical status 1-2 patients.
  • 18-60 years old .

排除标准

  • using or allergic to nonsteroidal anti inflammatory drugs (NSAIDs) or aspirin .
  • history of serious hepatic disease.
  • renal or gastrointestinal disease.
  • bleeding disorder.
  • body mass index BMI <18 or ˃30 m2/kg.
  • history of abdominal surgery or chronic pain disorder other than gallbladder.
  • disease or allergy to lidocaine.

研究组 & 干预措施

indomethacin group

Active Comparator

group indomethacin (40 patients) recived two 100 mg indomethacin rectal suppositories 2 hours prior to surgery

干预措施: Indomethacin suppository (Drug)

intraperitoneal lidocaine

Active Comparator

200 ml saline containing 200 mg 2%lidocaine immediately after abdominal cO2 insufflation( pneumoperitoneum) the surgeon sprayed the total solution on the upper surface of the liver under the right subdiaphragmatic space, left subdiaphragmatic space and around the cholecystectomy site , all patients were maintained in trendelenberg position

干预措施: Lidocaine 2% Injectable Solution (Drug)

结局指标

主要结局

VAS scores postoperative

时间窗: 24 hours posoperative

a standard 10-cm VAS was used, where one end of the scale represented no pain (0 cm), and the other end the most severe pain imaginable (10 cm), the distance in centimeters being taken as the pain score

postoperative opoiods analgesics requirements

时间窗: 24 hours postoperative

we used (iv pethidine )whenever the patient complained of pain. IV pethidine injection 25-50 mg was given as rescue analgesic whenever the patient experienced pain ≥ to 5 VAS

次要结局

  • Pain starting time after surgery and Pethidine required first time.(24 hours postoperative)

研究者

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

Gad Sayed Gad

assisstant professor

South Valley University

研究点 (1)

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