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临床试验/NCT05274113
NCT05274113Unknown3 期

Efficacy of Direct Versus Peripheral Low-Dose Adjuvant Dexamethasone on Duration and Rebound Pain in Regional Anesthesia for Distal Radius Fracture Fixation: A Prospective Randomized Controlled Blinded Study

Rothman Institute Orthopaedics1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年3月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
50
试验地点
1
主要终点
Postoperative pain control

研究概览

简要总结

The addition of the steroid dexamethasone to a single injection of local anesthetic has been shown to significantly prolong the duration of peripheral nerve blockade compared to local anesthetic alone. This allows for improved post-operative pain scores and reduces opioid use in the early post-operative period. However, the use of a steroid adjuvant in regional nerve blocks is generally not considered standard of care, and there is considerable variation among anesthesiologists regarding preferred formulations and the role of adjuvants in regional anesthesia. A recent study from our institution demonstrated the effectiveness of dexamethasone directly mixed with local anesthetic at multiple doses compared to placebo for upper extremity surgery. With this prospective randomized controlled blinded trial, we hope to definitively establish which method of adjuvant dexamethasone administration is superior in extending the effects of a brachial plexus nerve block.

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, Investigator)

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

  • Patients over the age of 18 undergoing open reduction and internal fixation of a distal radius fracture less than 3 weeks from injury with a volar plate technique
  • American Society of Anesthesiologists (ASA) levels 1 through 3 at time of surgery
  • Opioid naïve patients

排除标准

  • History of Drug/opioid/alcohol abuse
  • Polytrauma patients
  • History of inflammatory disorder, infection, dementia, psychiatric/neurological disorder, relevant drug/local anesthesia allergy, relevant chronic upper extremity pain (RSD, fibromyalgia, neuralgia, etc)
  • Excessive BMI
  • Pregnancy

研究组 & 干预措施

Group 1: Block with Ropivacaine + Dexamethasone

Active Comparator

Before surgery an ultrasound guided supraclavicular block with ropivacaine and 4 mg of dexamethasone will be administered

干预措施: Dexamethasone 4mg (Drug)

Group 1: Block with Ropivacaine + Dexamethasone

Active Comparator

Before surgery an ultrasound guided supraclavicular block with ropivacaine and 4 mg of dexamethasone will be administered

干预措施: Ropivacaine (Drug)

Group 2: Ropivacaine Block + IV Dexamethasone

Active Comparator

Before surgery an ultrasound guided supraclavicular block with ropivacaine will be administered and patients will receive dexamethasone intravenously

干预措施: Dexamethasone 4mg (Drug)

Group 2: Ropivacaine Block + IV Dexamethasone

Active Comparator

Before surgery an ultrasound guided supraclavicular block with ropivacaine will be administered and patients will receive dexamethasone intravenously

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Postoperative pain control

时间窗: 72 hours

Measured using participants Visual Analog Scale (VAS) pain scores

Postoperative pain control #2 questionnaire

时间窗: 72 hours

Measured by asking participants how much medication they take after surgery to help control their pain

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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