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临床试验/NCT01701115
NCT01701115已完成不适用

Effect of Local Anesthetic Dose on Interscalene Block for Shoulder Arthroscopy, Patient Satisfaction and Return of Handgrip Strength

Hospital for Special Surgery, New York1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2012年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
154
试验地点
1
主要终点
Handgrip Strength

研究概览

简要总结

The purpose of this study is to determine if a decrease in the standard volume of local anesthetic used to numb your shoulder area before shoulder arthroscopy will provide adequate anesthesia for the procedure and decrease the amount of time until you are ready for discharge from the hospital.

详细描述

Traditionally, an interscalene block is done either with nerve stimulator or ultrasound guided using 40-60mL of local anesthetic. The study plans to investigate the difference in hand grip strength post-operatively in patients who will receive interscalene blocks with 40mL versus a lower dose (20mL) of local anesthetic. We suspect the lower dose will achieve adequate surgical anesthesia while creating less motor block and thus, increase patient satisfaction, present fewer complications or adverse affects and decrease time in the recovery room.

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, Care Provider, 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

  • Age: 18 - 80 years old
  • Surgical time < 2.5 hours
  • ASA I, II or III
  • Shoulder arthroscopy

排除标准

  • Age < 18 or > 80 years old
  • Chronic pain patients (on narcotics/opioids > 3 months)
  • Open shoulder surgical procedure
  • BMI > 40
  • Pre-existing neurological condition
  • Patient refusal of interscalene block
  • Severe respiratory disease or hemidiaphragmatic dysfunction
  • Allergy to any local anesthetics
  • Planned general anesthesia

研究组 & 干预措施

Low Dose (20 mL) Local Anesthetic

Experimental

Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.

干预措施: Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block (Procedure)

Control Dose (40 mL) Local Anesthetic

Active Comparator

Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine

干预措施: Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block (Procedure)

结局指标

主要结局

Handgrip Strength

时间窗: Difference between between baseline and postoperative.

The primary outcome will be handgrip strength as measured by a dynamometer. A reading will be obtained at baseline (before the interscalene block) and 60 minutes post-operative.

次要结局

  • Patient Readiness to Discharge(Participants will be followed every 15 minutes post-surgery until discharged from the hospital (up to 180 minutes))
  • Duration of Analgesia(Postoperative Day 2)
  • Side Effects(Postoperative Day 2)

研究者

发起方
Hospital for Special Surgery, New York
申办方类型
Other
责任方
Sponsor

研究点 (1)

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