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
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
- 是
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
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
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
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
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
