Ultrasound-guided Median Nerve Block With Dextrose 5% Hydrodissection: Determination of the Minimal Effective Volume of Local Anesthetic
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
- 2
- 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
- 否
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
研究组 & 干预措施
median nerve block
An ultrasound-guided nerve block with dextrose 5% hydrodissection is performed in each case. The first patient will receive a 2 mL local anesthetic solution. For following patients, the volume of local anesthetic depends on the clinical result of the previous patient:
- increase of the volume (0.5 mL) in case of failure,
- no change or decrease (0.5 mol) in case of success; a randomization is made in this case (BCD method, Stylianou M, Flournoy N. Dose finding using the biased coin up-and-down design and isotonic regression. Biometrics 2002;58:171-7)
干预措施: median nerve block (Procedure)
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)