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临床试验/NCT03346993
NCT03346993已完成1 期

Can Latency of Action in Infraclavicular Brachial Plexus Block be Shortened With Warmed Bupivacaine?

Erzurum Palandöken State Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016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
1 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Evaluate sensory block's onset time

研究概览

简要总结

Brachial plexus blocks have some advantages, but also have some disadvantages as well. As with all nerve blocks, having to wait sometime for an effective block, sometimes failure to achieve an adequate block and possible requirement for isolated nerve block, having to wait a long time for resolution of the block, and immobilization of the extremity for some time can be seen as handicaps for brachial plexus block as well. In the present study, Study was aimed to compare the effects of bupivacaine warmed to body temperature and kept at room temperature on the onset time of ultrasound guided infraclavicular brachial plexus block.

详细描述

The study design was approved by the locale ethics committee. This double-blinded, randomized, controlled clinical trial recruited 60 patients aged between 18 and 65 years with the American society of anesthesiologists (ASA) physical status classification systems I/II and III who were candidated for surgical operations on any of the forearm, wrist and hand regions. All the participants were asked to sign an informed consent form after having been provided with details of the aim and proceedings of the study.

Patients were excluded from the study if they had a neurological and neuromuscular disorders, psychiatric problems, cardiopulmonary diseases, coagulopathy, infections or allergy to local anesthetic agents.

The patients were equally and randomly distributed into a 24C° 20 ml 0,5% bupivacaine group (Group 1), and 37C° 20 ml 0,5% bupivacaine group (Group 2) via closed envelope technique. All the participants were premedicated with 0.05 mg/kg of intravenous midazolam and monitored routinely before attempting nerve block.

Bupivacaine stored for at least 2 hours in a bain-marie (Memmert Waterbath WNB7, Germany) at 38˚C (regular temperature calibration was made) for Group 2.

The block process was accomplished by an anesthesiologist, who was blind to the temperature of bupivacaine and local anesthetic agent was administered by different anesthesiologist.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

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
否

入选标准

  • •Patients aged between 18 and 65 years
  • •American society of anesthesiologists (ASA) physical status classification systems I/II and III
  • •Candidate for surgical operations on any of the forearm, wrist and hand regions.

排除标准

  • •Neurological and neuromuscular disorders,
  • •Psychiatric problems
  • •Cardiopulmonary diseases
  • •Coagulopathy
  • •Sllergy to local anesthetic agents.

研究组 & 干预措施

24C° 0,5% bupivacaine group

Experimental

24C° 0,5% bupivacaine group will be performed USG guided infraclavicular block with 24C° 20 ml 0,5% bupivacaine

干预措施: Bupivacaine Hydrochloride 5 MG/ML (Drug)

37C° 0,5% bupivacaine group

Experimental

37C° 0,5% bupivacaine group will be performed USG guided infraclavicular block with 37C° 20 ml 0,5% bupivacaine

干预措施: Bupivacaine Hydrochloride 5 MG/ML (Drug)

结局指标

主要结局

Evaluate sensory block's onset time

时间窗: 30 minutes after Brachial Plexus Block

Pain was evaluated by pinprick test (yes-there is a pain/ no-there is no pain)

次要结局

  • Evaluate motor block's onset times(30 minutes after Brachial Plexus Block)

研究者

发起方
Erzurum Palandöken State Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Erkan Cem ÇELİK

Consult of Anesthesiologhy

Erzurum Palandöken State Hospital

研究点 (1)

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