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临床试验/NCT04442906
NCT04442906已完成不适用

Comparative Study Between Dexmedetomidine and Fentanyl as an Adjuvant to Intra-articular Bupivacaine for Postoperative Analgesia After Knee Arthroscopy.

Zagazig University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2020年7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
45
试验地点
1
主要终点
Duration of postoperative analgesia

研究概览

简要总结

The aim of this study is to evaluate analgesic effects Bupivacaine, Bupivacaine plus Dexmedetomidine and Bupivacaine plus Fentanyl in relieving pain after knee arthroscopic surgery.

详细描述

Forty-five patients ASA I - II aged 21-45 years for elective knee arthroscopy were divided into 3 groups: Group B, BD and BF. Group B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline. Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).

Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug). The time of first request of analgesia and analgesic effect by VAS during the first 24 hr. postoperatively are recorded.

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
Double (Participant, Outcomes Assessor)

盲法说明

anesthetist not sharing in the study will assess patient

入排标准

年龄范围
21 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Either sex,
  • Age 21-45 years,
  • American Society of Anesthesia (ASA) I - II for elective knee arthroscopy.

排除标准

  • The patients with history of hepatic and renal diseases, psychiatric disorders,
  • Prolonged intake of (NSAIDS, opioids and tricyclic antidepressant),
  • Allergy to study drugs and patient who received analgesics up to 24 hr. before surgery were excluded from this study.

研究组 & 干预措施

group B

Active Comparator

IGroup B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline

干预措施: Bupivacain (Drug)

group BD

Active Comparator

. Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).

干预措施: Dexmedetomidine (Drug)

group BD

Active Comparator

. Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).

干预措施: Bupivacain (Drug)

group BF

Active Comparator

Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug).

干预措施: Fentanyl (Drug)

group BF

Active Comparator

Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug).

干预措施: Bupivacain (Drug)

结局指标

主要结局

Duration of postoperative analgesia

时间窗: For 24 hours postoperative

start from intra-articular injection of the drug to the time of first request of analgesia

次要结局

  • total dose of rescue analgesia ( pethidine)(within 24 hours postoperative)
  • pain intensity at rest (static)(at 24 hours postoperative)
  • The number of participants with bradycardia, itching and hypotension(Within 24 hours postoperative)
  • patient satisfaction(within 24 hours postoperative)
  • pain intensity on mobilization of operated knee (dynamic)(at 24 hours postoperative)

研究者

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

Dina Abdelhameed Elsadek Salem

Principle investigator

Zagazig University

研究点 (1)

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