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临床试验/NCT02630290
NCT02630290已完成4 期

Addition of Dexmedetomidine to Ropivacaine-induced Supraclavicular Plexus Block, a Randomized Controlled Study

Guangzhou First People's Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Duration of analgesia

研究概览

简要总结

Dexmedetomidine, an alpha 2-adrenoreceptor agonist, has been found to exerts an excellent influences on the filed of perineural block. It could shorten the onset time and prolong the duration of the nerve block and improved postoperative pain. However, Dexmedetomidine-induced bradycardia or hypotension has recently attracted considerable attention because of potentially grave consequences, including sinus arrest and refractory cardiogenic shock. A low dose may help minimize cardiovascular risks associated with dexmedetomidine. However, few studies have addressed the clinical effects of low-dose dexmedetomidine as an perineural adjuvant. The present study was designed to test the hypothesis that low-dose dexmedetomidine added to ropivacaine would safely enhance the duration of analgesia without adverse effects when compared with ropivacaine alone. Investigators will conduct a single-center, prospective, randomized, triple-blind, controlled trial in patients undergoing elective forearm and hand surgery under ultrasound-guided supraclavicular brachial plexus block using either ropivacaine or ropivacaine plus low-dose dexmedetomidine. The primary outcome is self-reported duration of analgesia . Secondary outcomes include onset time and duration of motor and sensory block, total postoperative analgesics, and safety assessment (adverse effects and postoperative abnormal sensation).

详细描述

Dexmedetomidine, an alpha 2-adrenoreceptor agonist, has been found to exerts an excellent influences on the filed of perineural block. It could shorten the onset time and prolong the duration of the nerve block and improved postoperative pain. However, Dexmedetomidine-induced bradycardia or hypotension has recently attracted considerable attention because of potentially grave consequences, including sinus arrest and refractory cardiogenic shock. Although meta-analysis showed that perineural dexmedetomidine as a local anaesthetic adjuvant for neuraxial and peripheral nerve blocks produced reversible bradycardia in only 7% of brachial plexus block patients and no effect on the incidence of hypotension, various clinical studies reported a significant decrease in heart rate. A low dose may help minimize cardiovascular risks associated with dexmedetomidine. However, few studies have addressed the clinical effects of low-dose dexmedetomidine as an perineural adjuvant. The present study was designed to test the hypothesis that low-dose dexmedetomidine, which till today has not been reported in the literature, added to ropivacaine for brachial plexus block would safely enhance the duration of analgesia without adverse effects when compared with ropivacaine alone. Investigators will conduct a single-center, prospective, randomized, triple-blind, controlled trial in patients undergoing elective forearm and hand surgery under ultrasound-guided supraclavicular brachial plexus block using either 20 mL of 0.5% ropivacaine or 0.5% ropivacaine plus 30 microg dexmedetomidine. The primary outcome is self-reported duration of analgesia . Secondary outcomes include onset time and duration of motor and sensory block, total postoperative analgesics, and safety assessment (adverse effects including cardiovascular inhibitions and postoperative abnormal sensation). Data will be collected and analyzed in a blinded fashion.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • Surgery: elective forearm and hand surgery under ultrasound-guided supraclavicular brachial plexus block
  • American Society of Anesthesiologist(ASA) physical status of Ⅰ to III
  • Age between 18 to 60 years old

排除标准

  • Having an ongoing another clinical trials
  • Taking antihypertensive drugs such as methyldopa, clonidine and other α2 receptor agonist
  • Peripheral neuropathy
  • Cerebrovascular disease
  • Psychiatric disease
  • Coagulopathies
  • Pregnant women
  • Liver and kidney dysfunction
  • Heart failure
  • Known allergy or hypersensitive reaction to dexmedetomidine or anesthetic
  • Patient refusal

研究组 & 干预措施

Ropivacaine

Placebo Comparator

After a careful aspiration, 1 to 2 mL of normal saline is injected for a distribution in and around the brachial plexus. Additional needle tip repositioning and injections may be needed when the distribution is not attained. Then the study drug (0.5% ropivacaine in a total volume of 20 mL) will be injected with additional fine adjustment of the block needle under continuous ultrasound monitoring.

干预措施: Ropivacaine (Drug)

Ropivacaine + Dexmedetomidine

Experimental

After skin infiltration with 1-2 mL of lidocaine 2%, a 21-gauge 90-mm spinal needle will be inserted into the brachial plexus sheath using in-plane technique. After a careful aspiration, 1 to 2 mL of normal saline is injected for a distribution in and around the brachial plexus. Additional needle repositioning and injections may be needed when the distribution is not attained. Then the study drug (0.5% ropivacaine plus 30 microg dexmedetomidine in a total volume of 20 mL) will be injected with additional fine adjustment of the block needle under realtime ultrasound monitoring.

干预措施: Ropivacaine + Dexmedetomidine (Drug)

结局指标

主要结局

Duration of analgesia

时间窗: up to 24 hours postoperatively

Postoperative pain using visual analog scale (VAS, 0-100, 0 = no pain, 100 = maximum imaginable pain) will be assessed. Duration of analgesia is defined by time between administration of block and the postoperative pain \>3.

次要结局

  • Blood pressure (BP)(up to 24 hours postoperatively)
  • Heart rate (HR):(up to 24 hours postoperatively)
  • Peripheral oxygen saturation (SpO2)(up to 24 hours postoperatively)
  • Sensory block of median nerve(up to 30 minutes after administration of block)
  • Sensory block of ulnar nerve(up to 30 minutes after administration of block)
  • Sensory block of radial nerve(up to 30 minutes after administration of block)
  • Sensory block of musculocutaneous nerve(up to 30 minutes after administration of block)
  • Motor block of median nerve(up to 30 minutes after administration of block)
  • Motor block of ulnar nerve(up to 30 minutes after administration of block)
  • Motor block of radial nerve(up to 30 minutes after administration of block)
  • Abnormal sensation of brachial plexus(Day 1)
  • Motor block of musculocutaneous nerve(up to 30 minutes after administration of block)
  • Duration of motor block(up to 24 hours postoperatively)
  • Success rate of nerve block(30 minutes after administration of block)
  • Postoperative analgesic requirement(up to 24 hours postoperatively)
  • Postoperative nausea and vomiting (PONV)(up to 24 hours postoperatively)

研究者

发起方
Guangzhou First People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain

Director of Dept Pain, Principle Investigator, Professor

Guangzhou First People's Hospital

研究点 (1)

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