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临床试验/NCT04050891
NCT04050891已完成不适用

Comparative Study of Ultrasound Guided Combined Interscalene and Supraclavicular Brachial Plexus Block Versus General Anesthesia for Brachioaxillary Surgery in Renal Failure Patient

Mansoura University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
graft potency

研究概览

简要总结

The aim of this study is to evaluate the efficacy of combined supraclavicular and interscalene brachial plexus block in brachio-axillary surgeries in chronic renal failure as a sole anesthetic technique in comparison to general anesthesia.

详细描述

This randomized open blinded end-point pilot study was implemented at Mansoura University Hospitals. After acceptance of Institutional Research Board (No: MS/17.08.26), sixty patients of chronic renal failure, The American Society of Anesthesiologists (ASA) III, aged from 20 to 60 years old of either sex and planned for brachioaxillary graft interposition vascular surgery were enrolled.

Patients refusal, have allergy to local anesthetic, neurological, neuromuscular, psychiatric disorders, uncompensated hepatic, respiratory or cardiac disease, uncontrolled seizures, coagulation disorders, infection at the block injection site, body mass index more than 30 were excluded.

Written informed consents were obtained. Patients were classified using closed envelop method into two groups; group (GA) received general anesthesia; group (RA) received combined supraclavicular and interscalene block, each group were carried on 30 patients.

All patients were subjected to the preoperative assessment including history taking, clinical examination and assessment of ASA score. All patients subjected to dialysis session one day before the surgery. Basal laboratory investigation as complete blood count, coagulation profile (prothrombin time, international normalized ratio and activated partial thromboplastin time), arterial blood gases, Electrocardiography and echocardiography were done after dialysis.

After an overnight fasting, patients admitted to preanesthetic room where an intravenous (IV) cannula was inserted in the contralateral upper limb. Standard monitoring was applied to the patient include heart rate (HR), noninvasive blood pressure (NIBP), peripheral oxygen saturation (SpO2).

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • sixty patients of chronic renal failure,
  • aged from 20 to 60 years old
  • of either sex
  • planned for brachioaxillary graft interposition vascular surgery were enrolled.

排除标准

  • Patients refusal,
  • have allergy to local anesthetic,
  • neurological, neuromuscular, psychiatric disorders,
  • uncompensated hepatic, respiratory or cardiac disease,
  • uncontrolled seizures,
  • coagulation disorders,
  • infection at the block injection site,
  • body mass index more than 30

结局指标

主要结局

graft potency

时间窗: up to one month after surgery

by doppler

Pain assessment by numerical rating scale

时间窗: 24 hours after surgery

was explained to all candidates (zero = no pain and 10 = the worst pain)

satisfaction of the surgeon to the combined block supraclavicular and interscalene during operation

时间窗: 3 hours

by VAS from 0 to 100 as 0 represents unsatisfied and 100 represents satisfied

satisfaction of the patients to the combined block

时间窗: 3 hours

by VAS from 0 to 100 as 0 represents unsatisfied and 100 represents satisfied

次要结局

  • The onset and duration of sensory and motor block(30 minutes after block)
  • time to first intravenous analgesic requirement(24 hours after surgery)
  • Number of times of needed analgesia(24 hours after surgery)

研究者

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

Nevert Adel

MD Lecturer of Anesthesia and Surgical Intensive Care

Mansoura University

研究点 (1)

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