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临床试验/NCT02438657
NCT02438657已完成2 期

Ultrasound-guided Median Nerve Block With Dextrose 5% Hydrodissection: Determination of the Minimal Effective Volume of Local Anesthetic

Hopital Foch4 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2015年5月21日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
Hopital Foch
入组人数
52
试验地点
4
主要终点
Minimal effective volume of local anesthetic

研究概览

简要总结

Ultrasound guidance can reduce the required local anesthetic volume for successful peripheral nerve block.

The aim of the study is to determine the minimum volume of local anesthetic to achieve an ultrasound-guided median nerve block with a dextrose 5% hydrodissection approach.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 18 years from 18 to 80 years with an ASA (American Society of Anesthesiologists) physical status I-II
  • elective hand ambulatory surgery with a maximum duration of 30 minutes involving the median nerve and performed with elbow nerve blocks

排除标准

  • pregnant or lactating women,
  • contra-indication to regional anesthesia
  • diabetes mellitus,
  • effective anticoagulation or antiplatelet therapy, laboratory evidence of abnormal bleeding
  • neurological disease ( including carpal tunnel syndrome or neuromuscular disease detected by preoperative neurological examination in the median nerve)
  • infection at the puncture site
  • contra-indication to the administration of lidocaine, notably allergy
  • contra-indication to the administration of lidocaine with epinephrine
  • not speaking French
  • Exclusion from the study:
  • patient having an intraneural injection of the median nerve defined by swelling appearance are excluded from analysis

结局指标

主要结局

Minimal effective volume of local anesthetic

时间窗: 1 hour

Effective volume of local anesthetic to obtain a successful median nerve block block in 95% of patients defined as complete light touch block at the palmar aspect of the 2 distal phalanges of the index finger during a 30 minute evaluation period (mL)

次要结局

  • Success rate of the median nerve block(1 hour)
  • Duration of the block(1 day)
  • Nerve block onset time(1 hour)
  • Complications(1 month)
  • Block procedure time(One hour)
  • Additional local anesthetic(2 hours)
  • Duration of analgesia(1 day)

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (4)

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