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临床试验/NCT01829399
NCT01829399已完成4 期

Control of Tourniquet Pain With an Axillary Ring of Subcutaneous Local Anesthetic

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年4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
入组人数
24
试验地点
1
主要终点
Time in Minutes That Tq Remained Inflated

研究概览

简要总结

Purpose: Even with excellent regional anesthesia of the upper extremity, tourniquet (Tq) pain from an upper arm Tq can limit the ability to use regional anesthesia as the primary anesthetic for surgical procedures on the upper extremity. The aim of this study is to determine whether a subcutaneous ring of local anesthetic on the inner aspect of the upper arm just distal to axillary crease will significantly diminish Tq pain. If it does, peripheral nerve blocks distal to the Tq (i.e., nerve blocks at the elbow) could be used as the primary anesthetic for surgery of the hand and forearm. These distal peripheral nerve blocks have fewer complications than brachial plexus blocks performed at higher levels, and, postoperatively, the patient has better control of his or her arm when distal nerve blocks are used.

Procedures (methods): This is a prospective, cross-over study to examine the effectiveness of an upper arm Subcutaneous ring of local anesthetic alone in relieving Tq pain. This Subcutaneous ring of local anesthetic is often referred to as "Intercostobrachial nerve block" or "Subcutaneous ring anesthesia (SRA)." Twenty volunteers will be randomized into four groups of 5 participants each. During the initial experiment, the first group will be given SRA with 10-15 mL of 0.25% Bupivacaine with Epinephrine 1:200,000 on their dominant arm, the second group will be given SRA with 10-15 mL of 0.25% Bupivacaine with Epinephrine 1:200,000 on their non-dominant arm, the third group will be given "sham" SRA with saline on their dominant arm, and the fourth group will be given "sham" SRA with saline on their non-dominant arm. 15 minutes after SRA, a Tq will be applied to the arm with the subcutaneous injection and it will be inflated to 100 mm Hg above the subject's baseline systolic blood pressure. We will monitor heart rate, blood pressure (opposite arm) and pain (0 to 10 VAS) every 5 minutes. Each Tq will be released when the subject requests deflation or when 1 hour of Tq time has elapsed, whichever occurs first. The subject's discomfort level (VAS) just prior to deflation will be recorded. Since Tq pressure alone can inhibit nerve function, we will monitor motor and sensory function distal to the Tq every 10 minutes during Tq inflation and for 30 minutes after Tq deflation. One to two weeks after this initial study, the same 20 subjects will receive SRA on the same arm and the same parameters will be measured. The 10 subjects who received 0.25% Bupivacaine the first time will receive Normal Saline, and the 10 subjects who received Normal Saline the first time will receive 0.25% Bupivacaine. In this way, each subject will act as his or her own control.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteers will be eligible for the study if they meet all of the below criteria;
  • American Society of Anesthesiologists (ASA) classification I or II
  • 18 years of age to a maximum of 70 years of age
  • Exclusion criteria:
  • Pre-existing parasthesia or neuropathy of any kind
  • History of excessive alcohol consumption (> three drinks per night)
  • Take analgesics on a regular basis
  • History of any drug abuse
  • Baseline systolic blood pressure ≥ 150
  • Baseline diastolic blood pressure ≥ 85
  • BMI ≥ 30 Pregnancy Allergic reaction to local anesthetic

排除标准

  • 未提供

研究组 & 干预措施

Injected with Bupivacaine

Experimental

A subcutaneous axillary ring of 10 to 15 mL of 0.25% Bupivacaine with epinephrine 1:200,000 will be injected in the arm 15 minutes prior to tourniquet inflation.

干预措施: Bupivacaine with Epinephrine (Drug)

Injected with saline

Sham Comparator

A subcutaneous axillary ring of 10 to 15 mL of normal saline will be injected in the arm 15 minutes prior to tourniquet inflation.

干预措施: Normal Saline (Drug)

结局指标

主要结局

Time in Minutes That Tq Remained Inflated

时间窗: Tq was inflated 15 minutes after injection of Bupivacaine or placebo and remained inflated until subject could no longer tolerate it. Maximum allowable inflation time per session was 60 minutes.

15 minutes after either Bupivacaine or placebo injection, Tq was inflated to 100 mm Hg over subjects systolic blood pressure. When the subject found the Tq too uncomfortable, the Tq was deflated and the time documented. Approximately one month later, each subject had the opposite injection of either placebo or Bupivacaine on the same arm, and the duration of Tq inflation was again measured. Due to a strong crossover effect, only the data assessed from the first intervention was analyzed.

次要结局

  • Pain Score at Time of Tq Deflation(Tq will be deflated upon subject's request. VAS is assessed at time of deflation for degree of discomfort prompting deflation request, up to 60 minutes post intervention.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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