跳至主要内容
临床试验/NCT01495624
NCT01495624终止不适用

The Effect of Systemic or Perineural Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2011年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
16
试验地点
1
主要终点
duration of interscalene nerve block

研究概览

简要总结

Patients undergoing rotator cuff repair or subacromial decompression at the investigators institution are frequently hospitalized overnight due to inadequate pain relief after resolution of interscalene brachial plexus blocks. For ropivacaine 0.5%, the investigators usual local anesthetic, previous studies report an analgesic duration of 11.1 ± 5 hours without epinephrine and approximately 12 hours with epinephrine. Consequently, a method of prolonging analgesia from a brachial plexus block without the extra equipment and logistical difficulties of indwelling catheters would benefit both patients and caregivers. A potential approach is use of adjuvant drugs that prolong block duration when added to the local anesthetic.

In addition to the usual adjuvant anesthetic drugs, investigators have begun to evaluate glucocorticoids as adjuvants for regional anesthesia. Known for their anti-inflammatory, analgesic, immunosuppressive, and antiemetic properties, these corticosteroids exert their effects by inhibition of phospholipase A2 as well as changes in cell function induced by glucocorticoid receptor activation. Although associated with significant toxicity when administered in large doses for long periods, emerging literature suggests that a single perioperative dose of glucocorticoid is safe. Several studies, including a recent trial at the investigators institution, have demonstrated the efficacy of dexamethasone in prolonging regional anesthetics. Available data thus suggest that combining glucocorticoids with local anesthetics prolongs block duration. However, systemic glucocorticoids have also been shown to reduce postoperative pain. This raises the question whether the beneficial effects of adding glucocorticoid to a regional anesthetic is solely due to local effect or is mediated at least in part by systemic action. Previous trials, however, have not addressed this important issue. If this beneficial effect of analgesic duration is mediated by systemic action, adding dexamethasone to the local anesthetic mixture may be unnecessary. Although no study has reported neurotoxicity from perineural dexamethasone and laboratory data appear to confirm the safety of this route, achieving similar results with more conventional administration would be desirable for two reasons. First, conventional intravenous dosing is convenient, useful for other reasons (for example, postoperative nausea prophylaxis), and well-studied. Second, equivalent (or not equivalent) results from systemic dosing would provide valuable information about the mechanism behind dexamethasone's effect on block duration.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients undergoing shoulder procedures such as
  • •Rotator cuff repair
  • •Capsular shift
  • •Shoulder arthroplasty
  • •Subacromial decompression

排除标准

  • •Contraindications to interscalene block
  • •Coagulopathy
  • •Infection at the needle insertion site
  • •Moderate to severe chronic obstructive pulmonary disease (COPD)
  • •Contralateral pneumothorax or diaphragmatic paralysis
  • •Pregnancy
  • •Preexisting neuropathy involving the surgical limb
  • •Systemic glucocorticoid treatment (for at least one week) within six months of surgery
  • •Routine opioid use (greater than 30 mg oxycodone per day or equivalent)

研究组 & 干预措施

Ropivacaine with perineural dexamethasone

Placebo Comparator

30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic with 2 ml normal saline given intravenously (systemic placebo);

干预措施: ropivacaine plus dexamethasone anesthetic (Other)

Ropivacaine with systemic steroid

Active Comparator

30 ml 0.5% ropivacaine for interscalene block mixed with 2 ml normal saline (perineural placebo) plus dexamethasone 8 mg (2 ml) administered systemically.

干预措施: ropivacaine plus saline plus dexamethasone anesthetic (Other)

结局指标

主要结局

duration of interscalene nerve block

时间窗: Day one

The clinical duration of the interscalene nerve block, which will be measured by time from onset of sensory block until first administration of analgesic medication or requirement for initiation of the perineural catheter infusion.

次要结局

  • maximum VRS (Verbal Response Score) with rest(upon admission to PACU through post operative day 2, post operative day 14)
  • total opioid consumption(daily through post operative day 2)
  • increase in shoulder discomfort(as reported in minutes after procedure, day one)
  • Verbal Response Score (VRS) with movement(upon admission daily through post operative day 2, post operative day 14)

研究者

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

Kenneth Cummings III, MD, MS

Principal Investigator

The Cleveland Clinic

研究点 (1)

Loading locations...

相似试验