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临床试验/NCT02653144
NCT02653144已完成4 期

Double Blinded Randomized Controlled Study Evaluating the Analgesic Duration of Dexmedetomidine Compared to Dexamethasone as Adjuncts to Single Shot Interscalene Block in Patients Undergoing Ambulatory Shoulder Surgery

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2016年3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
105
试验地点
1
主要终点
Opioid Requirements (Morphine Equivalents)

研究概览

简要总结

The purpose of the study is to determine if perineural dexmedetomidine can provide increased prolongation of analgesia when compared to perineural dexamethasone in patients receiving regional block for shoulder surgery. If so, dexmedetomidine may serve as a superior adjunct to peripheral nerve blocks in a rapidly evolving, ambulatory-centered surgical setting.

详细描述

Currently, the most commonly employed adjunct to peripheral nerve blockade is perineural dexamethasone. In general, at the doses used in regional anesthesia, dexamethasone has a minimal side effect profile. However, while it has been shown to increase duration of analgesia, there have been concerns regarding its neurotoxicity in animal studies. In addition, dexamethasone has the potential to cause hyperglycemia in patients with impaired glucose metabolism as well as perineal pain and pruritis when administered peripherally.

Dexmedetomidine is a highly selective alpha-2 agonist that is commonly used in patients undergoing anesthesia or requiring sedation in a non-operative setting. As a peripherally administered medication, it has both sedating and analgesic properties, as well as the added benefit of avoidance of respiratory depression. Although it can rarely produce cardiac depression at high doses, its side effect profile is otherwise minimal and is generally very well tolerated by most patients. When administered peripherally, dexmedetomidine has most commonly been associated with side effects such as hypotension, respiratory depression, and bradycardia - although all at significantly higher doses than planned in our study. The safe use of perineural dexmedetomidine together with local anesthetics has been described on numerous occasions. Nevertheless, although it has been shown to potentiate peripheral nerve blockade and prolong duration of analgesia in various studies , it remains rarely used as an adjunct to regional anesthesia.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • ASA 3 and 4
  • Pre-existing pain disorder
  • Regular consumption of chronic pain medication
  • Anatomical abnormalities of upper extremity
  • Known allergy or hypersensitivity to Ropivacaine or other amide local anesthetics
  • Known allergy to dexmedetomidine
  • Coagulopathy
  • Uncontrolled Diabetes

研究组 & 干预措施

dexmedetomidine and ropivacaine group

Experimental

In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml + 75mcg of dexmedetomidine

干预措施: Ropivacaine (Drug)

dexmedetomidine and ropivacaine group

Experimental

In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml + 75mcg of dexmedetomidine

干预措施: Dexmedetomidine (Drug)

dexamethasone and ropivacaine group

Experimental

In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with. Ropivacaine 0.5% 20ml + 4mg dexamethasone

干预措施: Ropivacaine (Drug)

dexamethasone and ropivacaine group

Experimental

In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with. Ropivacaine 0.5% 20ml + 4mg dexamethasone

干预措施: Dexamethasone (Drug)

ropivacaine only group

Active Comparator

In this group, participants will undergo pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation with Ropivacaine 0.5% 20ml (acting as control)

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Opioid Requirements (Morphine Equivalents)

时间窗: 24 hours

How much opioid did patient ask for within 24 hours post op

次要结局

  • Opioid Requirements (Morphine Equivalents)(48 hours)
  • Time to Discharge From PACU to First Opioid Consumption(24-48 hours after surgery)
  • Return of Motor and Sensory Function(24-48 hours after surgery)

研究者

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

Amaresh Vydynathan

Assoc. Prof. Anesthesiology

Montefiore Medical Center

研究点 (1)

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