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临床试验/NCT02643563
NCT02643563已完成不适用

Comparison of the Analgesic Duration of 0.5% Bupivacaine With 1:200,000 Epinephrine Versus 0.5% Ropivicaine Versus 1 % Ropivicaine for Low Volume Ultrasound-guided Interscalene Brachial Plexus Block

Sunnybrook Health Sciences Centre1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年1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
入组人数
60
试验地点
1
主要终点
Duration of analgesic block

研究概览

简要总结

Severe pain following shoulder surgery is common and remains a major challenge. The interscalene nerve block is well suited for operations on the shoulder or upper arm, for providing surgical anesthesia as well as prolonged effective postoperative analgesia.

Modern ultrasound guided ISB (US-ISB) allows for more accurate, targeted deposition of local anesthetic. The current trend is to lower the volume of local anesthetic for ultrasound-guided interscalene block in order to reduce potential complications such as phrenic nerve paralysis and local anesthetic toxicity. However, at low volumes the analgesic duration of the block could be compromised. Studies to elucidate the best local anesthetic agent, concentration and adjuncts to prolong analgesia at low volumes are needed. Ropivacaine and Bupivacaine are long acting local anesthetics commonly used for peripheral nerve blocks, however, there are no studies comparing their analgesic duration in the setting of low volume interscalene block to date.

This study will investigate the analgesic duration of 0.5% Ropivacaine versus 0.5% Bupivacaine with 1:200,000 epinephrine versus 1% Ropivacaine for low volume US-ISB.

This study aims to conduct a comparison of the duration of post operative analgesia achieved by these agents, hence allowing the appropriate local anesthetic agent and concentration selection in low-volume techniques.

详细描述

Hypothesis:

0.5 % Bupivacaine with 1:200,000 epinephrine and 1% Ropivicaine provide longer duration analgesia than 0.5% Ropivicaine following a low dose ultrasound guided interscalene brachial plexus block (US-ISB)

Background and Rationale:

Severe pain following shoulder surgery is common and remains a major challenge. The interscalene approach to the brachial plexus is particularly well suited for operations on the shoulder or upper arm for providing surgical anesthesia as well as prolonged effective postoperative analgesia.

Despite the benefits, the interscalene approach may present risks and complications. Common complications of the interscalene nerve block include phrenic nerve blockade , Horner's syndrome, recurrent laryngeal nerve blockade, and vasculature puncture. Rare, but potentially devastating, complications include carotid artery puncture and intervertebral artery injection, pneumothorax, subdural injection, intervertebral foramina injection resulting in spinal or epidural anesthesia, nerve injury and local anesthetic toxicity have been reported.

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
Quadruple (Participant, Care Provider, 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

  • Patients undergoing arthroscopic shoulder surgery at Sunnybrook Health Sciences Centre
  • ASA functional status class I to III
  • BMI < 35 kg/m2

排除标准

  • Lack of patient consent
  • Allergy to bupivacaine or ropivacaine
  • BMI > 35 kg/m2
  • Contraindications to ISB including severe Chronic Obstructive Pulmonary Disease (Forced expiratory volume < 40% predicted), coagulopathy, pre-existing neurologic deficit in ipsilateral upper extremity, localized infection
  • Pregnant or nursing females
  • Chronic opioid use defined as > 30mg oral morphine equivalent per day

研究组 & 干预措施

Ropivacaine 0.5%

Experimental

Low volume (5 ml) Interscalene Block with Ropivacaine 0.5%

干预措施: Ropivacaine 0.5% (Drug)

Ropivacaine 1%

Active Comparator

Low volume (5 ml) Interscalene Block with Ropivacaine 1%

干预措施: Ropivacaine 1% (Drug)

结局指标

主要结局

Duration of analgesic block

时间窗: 48 hours

Defined as time from end of injection to first sensation of pain at surgical site

次要结局

  • Vital capacity(4 hours)
  • Diaphragmatic dysfunction assessed by ultrasound(4 hours)
  • Time to first opioid consumption(24 hours or less)
  • Duration of motor block(24 hours or less)
  • Opioid consumption(24 and 48 hours)
  • Pain VAS scores(4, 8, 12, 24, 48 hours)

研究者

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

Dr. Ben Safa

Anesthesiologist

Sunnybrook Health Sciences Centre

研究点 (1)

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