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临床试验/NCT03270033
NCT03270033已完成4 期

Analgesic Duration of Interscalene Block After Outpatient Arthroscopic Shoulder Surgery With Intravenous Dexamethasone, Dexmedetomidine or Their Combination: A Randomized Controlled Trial

University of Manitoba1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2017年9月18日最近更新:
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
198
试验地点
1
主要终点
Duration of analgesia after ISB

研究概览

简要总结

In this single-centre, double-blinded, randomized controlled superiority trial, 189 participants having outpatient, arthroscopic shoulder surgery will be randomized into 3 equal sized groups. All participants will receive a standardized interscalene brachial plexus block and 4mg of dexamethasone or 50mcg of dexmedetomidine or both intravenously just prior to their surgery. The purpose of this study is to provide a head to head comparison of two types intravenous adjuncts to ISB, corticosteroids and alpha 2 agonists, and determine if their combination, or either one alone provides superior postoperative analgesia in arthroscopic shoulder surgery patients, as well as possibly show a synergistic relationship between the two adjuncts. The investigators hypothesize the combination of adjuncts will provide a longer duration of analgesia compared to either single agent.

详细描述

BACKGROUND & RATIONALE Optimal postoperative analgesia is very important in the ambulatory arthroscopic shoulder surgery patient population; interscalene blocks are used for this surgery because they reduce acute pain and have opioid sparing effects postoperatively. While older patients, higher ASA grades and more complex arthroscopic procedures are risk factors for unplanned overnight admissions, in the ambulatory surgery setting, poor analgesia is one of the most common reasons a patient visits a health care provider after their surgery. Approximately 30 % of patients undergoing arthroscopic surgery globally experience significant postoperative pain within the first 24 hours post surgery. In light of this, interscalene brachial plexus blockade (ISB) has been found to be the most effective and preferred method of analgesia for arthroscopic shoulder surgeries when compared to subacromial/intra-articular injections, cryotherapy and oral pain medications. ISB usually consists of a single injection of local anesthetic, anywhere from 5 to 30 minutes prior to shoulder surgery. Although ISB reduces postoperative pain in arthroscopic shoulder surgeries, the length of analgesia from a single injection of local anesthetic is limited to 6 to 15 hours after surgery. Due to the limited duration of analgesia, interscalene catheters have been studied for prolongation of analgesia via continuous infusion of local anesthetics. Although continuous catheter infusions are effective and feasible, there exist several complications such as dyspnea, peripheral neuropathies, nausea, and practical challenges that limit their wider application in an ambulatory setting. Recently, different adjuncts given in combination with local anesthetics have been used to prolong the analgesic duration of a single injection ISB. These adjuncts have been given by both the intravenous and by the perineural routes, where perineural means the adjunct is injected with the local anesthetic around the brachial plexus.

Dexamethasone, a potent glucocorticoid, has been shown in multiple studies to prolong the duration of analgesia of the ISB compared to placebo when administered either perineurally or intravenously. A recently completed large trial (in press) at our centre showed that the duration of analgesia (mean (standard deviation), in hours (h)) with 4mg of intravenous dexamethasone (24.0 (4.6)h) is not significantly different from 8mg (24.8 (6.4)h) and only slightly shorter than perineural dexamethasone doses of 4mg (25.4 (6.6)h) or 8mg (27.2 (8.5)h). The 4mg intravenous dose was favored given the established safety of the intravenous route, its approximately equivalent effectiveness compared to the higher 8mg dose and the absence of differences in adverse effects between groups.

Dexmedetomidine, a highly selective α2 adrenergic agonist with sedative and analgesic properties, has also been shown to potentiate peripheral nerve blockade and prolong the duration of analgesia versus placebo when used as an adjunct to local anesthetic for regional anesthesia, including interscalene block. Most studies have compared perineural dexmedetomidine to placebo, as is the case for other adjuncts such as dexamethasone, even though there is less experience with the perineural route for dexmedetomidine compared to dexamethasone. Interestingly, a recent study found both intravenous and perineural dexmedetomidine reduced the 24 hour opioid consumption and comparably prolonged the duration of ISB analgesia compared to placebo. In a recent meta-analysis, a 50-60ug Dexmedetomidine perineural or intravenous dose maximized sensory block duration while minimizing hemodynamic side effects.

To our knowledge, there are no published studies comparing the analgesic duration of ISB between dexamethasone and dexmedetomidine, and no studies have evaluated whether there is additional benefit to administering these widely available medications in combination. Three ongoing studies are comparing dexamethasone and dexmedetomidine as single adjuncts, without a combination. All three of these studies are using the perineural route, despite the established safety and effectiveness of the intravenous route for both drugs. With this study we are seeking to improve our patients' postoperative experience with superior analgesia by better defining the relative analgesic effectiveness of dexamethasone and dexmedetomidine when given alone or in combination as intravenous adjuncts to ISB.

OBJECTIVES AND HYPOTHESES

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective ambulatory surgery patients undergoing arthroscopic shoulder surgery
  • Including rotator cuff repair
  • Stabilization procedures
  • Acromioplasty
  • Debridement and distal clavicle excision

排除标准

  • Patient refusal
  • Pregnancy
  • Coagulopathy significant enough to be a contraindication to regional anesthesia as determined by the attending anesthesiologist
  • Sensitivity to local anesthetics, dexamethasone or dexmedetomidine
  • Severe chronic obstructive pulmonary disease
  • Contralateral vocal cord paralysis
  • Contralateral diaphragmatic paralysis
  • Surgical limb brachial plexus neuropathy
  • Interscalene block site infection
  • Systemic glucocorticoids in the last 2 weeks
  • Epidural or intraarticular steroid injection in the past 3 months
  • Chronic opioid use defined as daily use for the last two weeks
  • Active peptic ulcer disease
  • End-stage renal disease
  • Cirrhotic liver disease
  • Ventricular dysfunction
  • Advanced heart block
  • Previous participation in the study.

研究组 & 干预措施

Dexamethasone

Active Comparator

4 milligrams dexamethasone administered once intravenously with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block

干预措施: Dexamethasone (Drug)

Dexmedetomidine

Active Comparator

50 micrograms dexmedetomidine administered once intravenously with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block

干预措施: Dexmedetomidine (Drug)

Dexamethasone and Dexmedetomidine

Active Comparator

4 milligrams dexamethasone and 50 micrograms dexmedetomidine administered once intravenously with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block

干预措施: Dexamethasone (Drug)

Dexamethasone and Dexmedetomidine

Active Comparator

4 milligrams dexamethasone and 50 micrograms dexmedetomidine administered once intravenously with a 30 millilitres 0.5% bupivacaine interscalene brachial plexus block

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Duration of analgesia after ISB

时间窗: Time-to-event outcome measure, assessed up to the end of postoperative day 3 (approximately 84 hours from performance of the block

Time from block performance to the first time shoulder pain was experienced after the surgery, rounded to the nearest 0.1 hours, as reported by the participant at telephone follow-up on postoperative day one, or if necessary, postoperative day 2.

次要结局

  • Cumulative Analgesic Consumption in the post anesthesia care unit("Change" outcome measure: From admission to the post anesthesia care unit (an expected average of 2.5 hours after performance of the block), to discharge from the post anesthesia care unit (an expected average of 4 hours after performance of the block))
  • Block Success or Failure(Assessed at discharge from the post anesthesia care unit, an expected average of 5 hours after the performance of the block.)
  • Cumulative Analgesic Consumption from post anesthesia care unit discharge until the time the primary outcome occurred("Change" outcome measure: From discharge from the post anesthesia care unit (an expected average of 5 hours after performance of the block), to the occurrence of the primary outcome (an expected average of 28 hours after performance of the block))
  • Post anesthesia care unit length of stay in minutes(Assessed at discharge from the post anesthesia care unit, an expected average of 4 hours after performance of the block.)
  • New Persistent Neurologic Symptoms(Assessed at postoperative day 14)
  • The QoR-15 questionnaire(Assessed at postoperative day one.)
  • Unplanned Postoperative Hospital Admission, as reported at telephone follow up or chart review(Assessed at telephone follow up on postoperative day one and chart review)

研究者

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

Thomas Mutter

Assistant Professor of Anesthesia

University of Manitoba

研究点 (1)

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