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临床试验/NCT04692896
NCT04692896已完成1 期

Effect of Different Concentrations of Lidocaine in Relieving Pain Peroperatively and 24 Hours Postoperatively in Wide Awake Hand Surgery Using Tumescent Local Anesthesia Technique

King Edward Medical University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年9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
入组人数
90
试验地点
1
主要终点
total duration of analgesia

研究概览

简要总结

Lidocaine has been used along with adrenaline in tumescent anesthesia for a variety of procedures. This has been quite popular especially in wide awake surgery of the hand with no tourniquet. However, the appropriate lidocaine concentration is yet to be established. This randomized control trial will study the minimum effective lidocaine concentration in hand surgery using the tumescent technique.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 16 to 60 years of either gender
  • Patients with post burn/post traumatic contractures involving fingers & palm
  • Patients with nerve injury or flexor/extensor tendons injury distal to mid forearm.

排除标准

  • Patients with history of ischemic heart disease, chronic liver disease (ALT/AST 40 IU/L), renal disease (creatinine 13mg/dl), bleeding disorder, peripheral arterial disease & peripheral neuro3pathy .
  • Surgical site infection .
  • History of allergic hypersensitivity to epinephrine or lidocaine.

研究组 & 干预措施

0.1% lidocaine

Experimental

干预措施: lidocaine (Drug)

0.2% lidocaine

Experimental

干预措施: lidocaine (Drug)

0.3% lidocaine

Experimental

干预措施: lidocaine (Drug)

结局指标

主要结局

total duration of analgesia

时间窗: Within 24 hours of randomization.

Patients were randomized to either 0.1percent, 0.2 percent and 0.3 percent groups. Tumescent local anesthesia was infiltered. Surgery was started approximately 25 minutes after the infiltration. Start of surgery was designated 0 minute. Duration of pain free surgery was noted in minutes. Pain scores was measured after surgery. When pain scores was equal to or more than 4, analgesia was given and total time in minute from start of surgery till this time was taken as total duration of analgesia.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammad Mustehsan Bashir

Professor of Plastic Surgery

King Edward Medical University

研究点 (1)

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