Analgesic Efficacy of Perineural Dexamethasone Added to Ropivacaine 0.5% With 1:400,000 Epinephrine During Single-injection Supraclavicular Block for Outpatient Hand Surgery
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 主要终点
- Time to First Analgesic Dose
研究概览
简要总结
The purpose of this study is to determine whether the addition of dexamethasone prolongs analgesia when added to long-acting local anesthetic during single-injection supraclavicular block for outpatient hand surgery.
详细描述
The goal for pain control after surgery is to provide the best possible pain control for the longest period of time with the least amount of side effects. One type of pain medication is called local anesthetic, which is a numbing medication that is injected in the area surrounding nerves to block pain. This injection is called a nerve block. Ropivacaine is a local anesthetic that is commonly used for nerve blocks and will be used in this study. The effects of ropivacaine may last for 8 to 12 hours after surgery. Recent research studies have shown that adding a medication called dexamethasone (a steroid) may increase the time that the nerve block will provide pain control. The purpose of this study is to see if adding dexamethasone to ropivacaine and injecting this around the nerves during a supraclavicular brachial plexus block increases the duration of pain relief as compared to both placebo control and systemic control groups.
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
- 否
入选标准
- •Patients 18 years of age and older
- •Patients scheduled for elective outpatient hand surgery with same day discharge at the Duke Ambulatory Surgery Center
排除标准
- •Patients who refuse regional anesthesia
- •Patients in whom peripheral nerve block is contraindicated
- •Patients unable to sign/understand consent
- •Patients with significant language barriers who cannot comply with data collection process
- •Patients with known allergies to local anesthetics
- •Pregnancy
- •Chronic pain patients or patients requiring chronic opioid treatment
- •Patients with a history of diabetes
- •Patients with contraindication to steroid administration (allergy, chronic steroid use)
研究组 & 干预措施
ropivacaine + dexamethasone
This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.
干预措施: Ropivacaine (Drug)
ropivacaine + dexamethasone
This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.
干预措施: Dexamethasone (Drug)
ropivacaine + placebo
This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.
干预措施: Ropivacaine (Drug)
ropivacaine + placebo
This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.
干预措施: Placebo (Other)
ropivacaine + dexamethasone + placebo
This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.
干预措施: Ropivacaine (Drug)
ropivacaine + dexamethasone + placebo
This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.
干预措施: Dexamethasone (Drug)
ropivacaine + dexamethasone + placebo
This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.
干预措施: Placebo (Other)
结局指标
主要结局
Time to First Analgesic Dose
时间窗: 48 hours
次要结局
未报告次要终点