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临床试验/NCT07024043
NCT07024043进行中(未招募)1 期

Effect of Dexamethasone Versus Dexmedetomidine as A Local Anesthetic Adjuvant In IPACK Block for Post Operative Analgesia Following Arthroscopic Knee Surgeries

Ain Shams University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年3月3日最近更新:
干预措施
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
75
试验地点
1
主要终点
Efficacy of Dexamethasone versus Dexmedetomidine in IPACK Block to reduce pain post Arthroscopic knee surgeries

研究概览

简要总结

The investigators will test the effects of dexamethasone versus dexmedetomidine as adjuvant to bupivacaine in IPACK Block and it's direct effect in decreasing pain post operative following Arthroscopic knee surgeries

详细描述

A.Preoperative settings: All patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation. An informed written consent will be taken from every patient just before the surgery. B.Intraoperative and postoperative settings: On arrival to the operating room, baseline parameters such as ECG, mean arterial blood pressure, heart rate, and oxygen saturation will be recorded. Intravenous line will be inserted and IV Ringer's solution will be started, 500ml bolus will be given as a preload over 20 min before performing spinal anaesthesia and maintenance volume of 10ml\kg. For each group, patients will be put in supine position, the procedure will be performed under complete aseptic precautions and All patients will be divided into three groups:(Group 1) for iPACK block with 0.25% bupivacaine only. (Group 2) for iPACK block with 0.25% bupivacaine and dexamthasone and (Group 3) for iPACK block with 0.25% bupivacaine and dexmedetomidine .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • Physical status: ASA I,II. Both sexes. BMI<35

排除标准

  • Refusal of the procedure or participation in the study by the patient. Physical status: ASA III or Above. History of allergy to the study drug. Evidence of local infection at site of injection. Major hepatic, renal, or cardiovascular dysfunction. BMI>35.

研究组 & 干预措施

(Group 1) for iPACK block with 0.25% bupivacaine only. (Group 2) for iPACK block with 0.25% bupivac

Experimental

For each group, patients will be put in supine position, the procedure will be performed under complete aseptic precautions and All patients will be divided into three groups:(Group 1) for iPACK block with 0.25% bupivacaine only. (Group 2) for iPACK block with 0.25% bupivacaine and dexamthasone and (Group 3) for iPACK block with 0.25% bupivacaine and dexmedetomidine .

干预措施: Dexamethasone versus Dexmedetomidine in IPACK Block to reduce pain post Arthroscopic knee surgeries (Drug)

(Group 1) for iPACK block with 0.25% bupivacaine only. (Group 2) for iPACK block with 0.25% bupivac

Experimental

For each group, patients will be put in supine position, the procedure will be performed under complete aseptic precautions and All patients will be divided into three groups:(Group 1) for iPACK block with 0.25% bupivacaine only. (Group 2) for iPACK block with 0.25% bupivacaine and dexamthasone and (Group 3) for iPACK block with 0.25% bupivacaine and dexmedetomidine .

干预措施: IPACK and multi-modal analgesic regimen (Procedure)

结局指标

主要结局

Efficacy of Dexamethasone versus Dexmedetomidine in IPACK Block to reduce pain post Arthroscopic knee surgeries

时间窗: 45 minutes after spinal anaesthesia

postoperative analgesic effect will be assessed by the time till first analgesic requirement which is defined as the time (in hours) after finishing of ultrasound guided iPACK block till the patient's requirement for first analgesia postoperative in ward. Postoperative pain will be assessed by visual analog scale (VAS) up to 24 h after surgery. Whenever VAS score reached ≥ 4, rescue analgesia will be given in the form of iv injection diclofenac sodium 75 mg. Time to the first dose of diclofenac sodium postoperatively will be recorded

次要结局

  • Effect Of Dexamethasone Versus Dexmedetomidine as A Local Anesthetic Adjuvant In IPACK Block for Post Operative Analgesia following Arthroscopic Knee Surgeries(45 minutes after spinal anesthesia)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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