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临床试验/NCT01620112
NCT01620112已完成2 期

The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine for Upper Limb Surgery: a Prospective Randomized Study

Universidade Federal do Rio de Janeiro0 个研究点目标入组 60 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
60
主要终点
sensorial and motor block duration

研究概览

简要总结

The purpose of this study is to determine whether different clonidine concentration on axillary brachial plexus block with 1,5% lidocaine for upper limb surgery may influence the sensory and motor block onset time and duration, postoperative analgesia duration, postoperative pain intensity

详细描述

Brachial plexus blocks are frequently used in surgical procedures involving the upper limb because they facilitate surgical anaesthesia, muscle relaxation and post-operative analgesics.

Various drugs are used to supplement local anaesthetics during brachial plexus block. Many studies in the literature show that clonidine, which is an alpha-2 agonist, prolongs the length of anesthesia and post-operative analgesia.4,5 However, clonidine's side effects-such as hypotension, bradycardia and sedation can limit its use.

There are no studies comparing different clonidine concentrations on the axillary brachial block, so the hypothesis of the present study was that different clonidine concentrations and LA volumes may influence the anaesthesia and analgesia quality on this type of regional block.

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
Single (Care Provider)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • both genders,
  • over 18 years old,
  • American Society of Anesthesiologists (ASA) 1 to 3

排除标准

  • patients with chronic use of analgesics and non-steroidal anti-inflammatories drugs,
  • pregnant,
  • with infection at the puncture site,
  • coagulopathies or intolerance to drugs used in the study

研究组 & 干预措施

low clonidine concentration

Active Comparator

clonidine concentration 1 ml on 40 ml of lidocaine 1.5% for upper brachial plexus

干预措施: low clonidine concentration (Drug)

lidocaine 20 ml 1,5%

Active Comparator

lidocaine 20 ml 1,5% without clonidine for axillary brachial plexus block for upper limb surgery

干预措施: Lidocaine (Drug)

high clonidine concentration

Active Comparator

clonidine concentration 150 mcg on 20 ml of lidocaine 1,5% for upper brachial plexus

干预措施: high Clonidine concentration (Drug)

40 ml lidocaine 1,5%

Active Comparator

40 ml of lidocaine 1,5% without clonidine for upper brachial plexus

干预措施: Lidocaine 40 ml (Drug)

结局指标

主要结局

sensorial and motor block duration

时间窗: 24 hours after surgery

to compare two concentrations of clonidine on different volumes of lidocaine, in terms of sensorial and motor block duration

次要结局

  • adverse effects of additive clonidine on axillary brachial plexus block in upper limb surgery(24 hours after surgery)
  • postoperative analgesia duration(24 hours)
  • sensorial and motor block onset time(24 hours)
  • postoperative pain intensity(24 hours)

研究者

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

Alexandra Rezende Assad

Assad AR

Universidade Federal do Rio de Janeiro

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