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临床试验/NCT02322242
NCT02322242已完成4 期

Comparison of the Effects of Perineural Versus Systemic Dexamethasone on Low Dose Interscalene Brachial Plexus Block: A Randomized Control Trial

Dr. Stephen Choi1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2015年1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
182
试验地点
1
主要终点
Duration of Sensory Block

研究概览

简要总结

A standard interscalene nerve block is performed with long acting local anesthetic (bupivacaine or ropivacaine in concentrations varying from 0.25% to 0.75%). The purpose of this study is to investigate the effect of the addition of perineural dexamethasone (4mg) to a standard ropivacaine solution (0.5%) on analgesic duration of low dose interscalene block compared to ropivacaine alone for interscalene block with systemic dexamethasone.

Ropivacaine is not an intervention as a local anesthetic is pre-requisite to performing a nerve block.

详细描述

Interscalene brachial plexus block (ISB) is regarded as the standard of care for analgesia after shoulder surgery providing superior analgesia and reducing opioid consumption. Shoulder surgery, previously requiring inpatient admission for pain control, is now commonly performed on an ambulatory basis facilitated by ISB analgesia. The effects of single injection ISB dissipate after several hours unmasking the moderate to severe pain of the surgical insult and require strong opioid analgesia. Efforts to prolong ISB duration by increasing local anaesthetic (LA) dose are limited by their pharmacodynamics and narrow therapeutic window. To address some of these issues faced with prolonging ISB analgesia the addition of perineural adjuvants to local anesthetic (eg. clonidine, dexmedetomidine), have been investigated in an attempt to prolong peripheral nerve block duration with limited success. However, the corticosteroid dexamethasone, has been added to local anesthetic solutions for ISB and has demonstrated promise in preliminary studies. Perineural dexamethasone (8-10mg) in conjunction with local anesthetic prolongs the duration of ISB with an effect sizes ranging from 40% to 75% (absolute effect ~ 6 to 10 hours). Dexamethasone, however, is only approved for intramuscular or intravenous administration and therefore perineural use is currently off-label. There are several reasons that warrant a new randomized trial. Chiefly, all of the previous trials do not reflect modern regional anesthetic practice. These trials utilized peripheral nerve stimulation (PNS) and local anesthetic volumes of 30 to 40 ml. Modern ultrasound guided ISB (US-ISB) allows for more accurate, targeted deposition of local anesthetic with volumes ranging from 5 to 10 ml with no difference in block efficacy or duration compared to larger volumes (≥20ml). An ideal solution would be a local anesthetic with adjuvant mixture that allowed administration of lower volumes but with prolonged analgesic duration. The use of low dose local anesthetic with dexamethasone could be one such solution. A trial that demonstrates enhanced block quality and duration associated with perineural dexamethasone added to low dose local anesthetic may allow us to achieve both prolonged duration of effect and reduced side effects due to unwanted local anesthetic spread. This would create further significant benefits for patients and further promote the use of low dose local anesthetic techniques to anesthesiologists who do not currently use this technique.

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
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, Toronto Western Hospital and Women's College Hospital.
  • ASA functional status class I to III
  • Age 18 to 80 years
  • BMI ≤ 35 kg/m2

排除标准

  • Lack of patient consent
  • Allergy to dexamethasone or ropivacaine
  • BMI > 35 kg/m2
  • Contraindications to low dose dexamethasone including peptic ulcer disease, systemic infection, glaucoma, active varicella/herpetic infections, diabetes mellitus
  • 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 or equivalent per day
  • Unable to take acetaminophen or celecoxib

研究组 & 干预措施

Perineural Dexamethasone

Active Comparator

ISB performed with local anesthetic (ropivacaine 0.5%) and perinerual dexamethasone (4mg)

干预措施: Perineural dexamethasone (Drug)

Systemic Dexamethasone

Other

ISB with local anesthetic alone (ropivacaine 0.5%) alone and intravenous dexamethasone (4mg)

干预措施: Systemic Dexamethasone (Drug)

结局指标

主要结局

Duration of Sensory Block

时间窗: 1 day postoperative

Defined as time from completion of block procedure to NRS for pain \> 0 (in hours)

次要结局

  • Postoperative Serum Blood Glucose(1 hour postoperative)
  • Time to First Opioid Consumption(1 day postoperative)
  • Duration of Motor Block(1 day postoperative)
  • Post-operative Oxygen Saturation on Room Air(1 hour postoperative)
  • Opioid Consumption(7 days postoperative)
  • Numeric Rating Scale for Pain (NRS 0-10)(7 days postoperative)
  • Number of Participants With Nerve Damage From Interscalene Block(7 Days postoperative)
  • Infection(7 Days postoperative)
  • Number of Participants With Postoperative Nausea and/or Vomiting(7 days postoperative)

研究者

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

Dr. Stephen Choi

Assistant Professor and Staff Anesthetist, Department of Anesthesia

Sunnybrook Health Sciences Centre

研究点 (1)

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