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临床试验/NCT04694105
NCT04694105已完成不适用

Peri-neural Dexmedetomidine Versus Dexamethasone as an Adjuvant to Bupivacaine Single Injection in Ultrasoundguided Supraclavicular Brachial Plexus Block for Arteriovenous Fistula: A Randomized Controlled Study

Cairo University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2018年6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
42
试验地点
1
主要终点
Duration of analgesia

研究概览

简要总结

to assessthe impact of addition of Dexmedetomidine or Dexamethasone to Bupivacaine, on Duration of analgesia (time in hours to the first report of postoperative pain )at the surgical site

详细描述

This randomized, controlled double blinded study included 42 adult patients undergoing arteriovenous fistula surgery. Ultrasound-guided supraclavicular brachial plexus block was initiated after placement of full monitoring . Supraclavicular brachial plexus block was achieved with the use of total volume 32 ml of anesthetic drugs in all patients. Bupivacaine 30 ml 0.25% was combined with 2 ml normal saline (control group A, n=14), Bupivacaine 30 ml 0.25% was combined with 50 microgram (0.5 ml) peri-neural dexmedetomidine plus 1.5 ml normal saline ( dexmedetomidine group B ,n=14), or Bupivacaine 30 ml 0.25% was combined with 4 mg peri neural dexamethasone (2 ml) ( dexamethasone group C, n=14).The onset and duration of sensory and motor blocks, the time to first request to postoperative rescue analgesic, Richmond Agitation-Sedation Score, hemodynamic data, visual analogue pain scores, were reported at predetermined time assessment points. Postoperative rescue intravenous fentanyl consumption over 24 hours and complications occurred were recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Care Provider)

盲法说明

double blind both anesthetist and patient not aware about type of local anesthesia

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

  • All the patients included in the study aged 18 to 60 years old were on chronic hemodialysis and they had a hemodialysis session one day before the block performance

排除标准

  • Neurological, neuromuscular, psychiatric disorders, hepatic, respiratory, or cardiac diseases; coagulation disorders; infection at the block injection site; patients with a body mass index more than 35; or patients who refused the procedure

研究组 & 干预措施

dexmedetomidine

Active Comparator

Bupivacaine 30 ml 0.25% was combined with 50 microgram (0.5 ml) peri-neural dexmedetomidine plus 1.5 ml normal saline

干预措施: Dexmedetomidine injection (Drug)

dexamethasone

Active Comparator

Bupivacaine 30 ml 0.25% was combined with 4 mg peri neural dexamethasone (2 ml)

干预措施: Dexamethasone (Drug)

control group

Placebo Comparator

Bupivacaine 30 ml 0.25% was combined with 2 ml normal saline

干预措施: saline (Drug)

结局指标

主要结局

Duration of analgesia

时间窗: "UP to 4 hours post operative"

(time in hours to the first report of postoperative pain at the surgical site, administered of opioid when VAS score was\>4).

次要结局

  • Pain scores.("at 8 and 24 hours post operative")

研究者

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

mahmoud salem soliman

Head of intensive care unit at new kaser al ainy teaching hospital , lecterur of anaesthesia and intensive care cairo universty

Cairo University

研究点 (1)

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