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临床试验/NCT06535256
NCT06535256已完成不适用

Comparison of Intraperitoneal Instillation of Bupivacaine with Dexmedetomidine Versus Bupivacaine with Dexamethasone on Postoperative Pain After Laparoscopic Cholecystectomy

Aswan University 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1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
incidence and severity of postoperative pain for 24 hours

研究概览

简要总结

Comparison of intraperitoneal instillation of bupivacaine with dexmedetomidine versus bupivacaine with dexamethasone on postoperative pain after laparoscopic cholecystectomy

详细描述

Laparoscopy has become the preferred mode for many diagnostic and operative procedures. It has the advantage better cosmetic results, faster recovery, short post-operative hospital stays, and early resumption of normal activities. Post-laparoscopic pain results from stretching of the intra-abdominal cavity, peritoneal inflammation, and diaphragmatic irritation caused by residual carbon-dioxide in the peritoneal cavity is very annoying to the patients.

Although the severity of pain after a laparoscopic procedure is less compared to laparotomy, but it is acute and can lead to increased analgesic requirements and prolonged hospital stays.

Several studies have evaluated post-laparoscopic pain relief methods such as intravenous analgesics analgesic patches, steroids, and intra-peritoneal instillation of local anaesthetics alone or with additives.

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
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
是

入选标准

  • •Patients scheduled for laparoscopic cholecystectomy
  • •Age 18-60 years
  • •American Society of Anesthesiologists (ASA) physical status I-II

排除标准

  • •Patients with diabetes mellitus
  • •Allergy to the study drugs
  • •Patients on steroids
  • •Pregnant females
  • •Patients with cardiac, pulmonary, hepatic or renal disorders

研究组 & 干预措施

bupivacaine with dexmedetomidine

Active Comparator

40 mL of 0.25% bupivacaine + dexmedetomidine 1 μg/kg with normal saline 5 ml).

干预措施: bupivacaine with dexmedetomidine (Combination Product)

bupivacaine with dexamethasone

Active Comparator

40 mL of 0.25% bupivacaine + 16 mg dexamethasone with 5 ml normal saline).

干预措施: bupivacaine with dexamethasone (Combination Product)

结局指标

主要结局

incidence and severity of postoperative pain for 24 hours

时间窗: severity of postoperative pain measured at 1, 2, 4, 8, 16, and 24 hours. postoperatively, using Visual Analogue Scale

using VAS pain score

次要结局

未报告次要终点

研究者

发起方
Aswan University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zaher Zaki Zaher

Lecturer

Aswan University Hospital

研究点 (1)

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