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临床试验/NCT02073383
NCT02073383Unknown不适用

Prospective Randomized Study of Three Different Techniques for Ultrasound Guided Axillary Brachial Plexus Block

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 313 人开始时间: 2013年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
313
试验地点
2
主要终点
The primary outcome is to compare the efficacy of the three different techniques for ultrasound guided axillary brachial plexus block

研究概览

简要总结

The brachial plexus block is an anesthetic technique often used for surgical procedures of the upper limb. The brachial plexus block through the axilla (BPVA) is one of the techniques most commonly used to obtain regional anesthesia of the upper limbs, being performed by anesthesia of the terminal branches of the brachial plexus, which would be the ulnar, median, radial and musculocutaneous nerves. With the aid of ultrasound , two techniques can be used to perform the BPVA . The first , known as multiple puncture technique , the local anesthetic is deposited around each nerve that want to block . This technique is most commonly used to perform the BPVA . The second technique , known as 2 injections , local anesthetic is deposited below the axillary artery and around the musculocutaneous nerve . This technique has been proposed to try to reduce the execution time of anesthesia . Studies actually show that the technique of 2 injections showed less time to perform the block, with the same success rate. However, the technique of 2 injections showed a longer latency and higher rate of vascular puncture . (14) In order to perform a procedure with shorter execution time , without changing the latency, success rate and ensuring patient safety , the investigators designed this protocol to evaluate three techniques for performing the ultrasound- guided axillary brachial plexus 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
Triple (Participant, Investigator, Outcomes Assessor)

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

  • Informed consent signed by the patient (IC)
  • Indication for brachial plexus block for anesthesia and analgesia in candidates for hand surgical procedures
  • ASA physical status I, II or III according to the American Association of Anesthesiology.

排除标准

  • Cognitive impairment or psychiatric disease
  • Active infection condition at the puncture site of the block
  • Bleeding disorders
  • History of allergy to bupivacaine.

研究组 & 干预措施

Around Artery

Experimental

Intervention Name: Axillary brachial plexus block

Group A: 30 ml of 0.375% bupivacaine will be injected around the artery . If this were a clock, would deposit 7,5 ml of anesthetic in positions 0, 3, 6 and 9 .

干预措施: Axillary brachial plexus block (Procedure)

Two injections

Experimental

Group 2: 30 ml of bupivacaine 0.375 % below the artery will be injected in the 6 o'clock position .

干预措施: Axillary brachial plexus block (Procedure)

Perineural

Active Comparator

Group Perineural : 10 ml of bupivacaine 0.375 % will be injected around the median, ulnar and radial nerves .

干预措施: Axillary brachial plexus block (Procedure)

结局指标

主要结局

The primary outcome is to compare the efficacy of the three different techniques for ultrasound guided axillary brachial plexus block

时间窗: The primary outcome will be measured at the same day of the procedure.

The brachial plexus block is performed through the axilla , with the aid of ultrasound and a peripheral nerve stimulator with the patient in the supine position. The needle that will be used is 22G x 50 mm . After disinfection and skin antisepsis with chlorhexidine , tha puncture site will be infiltrated with 1% lidocaine . Furthermore, musculocutaneous nerve will be blockade with 10 ml of 0.375% bupivacaine for all patients. Patients will be divided into three groups : Group A: 30 ml of 0.375% bupivacaine will be injected around the artery . If this were a clock, would deposit 7,5 ml of anesthetic in positions 0, 3, 6 and 9 . Group 2 injections : 30 ml of bupivacaine 0.375 % below the artery will be injected in the 6 o'clock position . Group M : 10 ml of bupivacaine 0.375 % will be injected

次要结局

  • Block Latency(30 minutes)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leonardo Henrique Cunha Ferraro

MD

Federal University of São Paulo

研究点 (2)

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