Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block: a Randomized Double-blinded Placebo Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- duration of analgesia
研究概览
简要总结
The goal of the study is to compare the duration of analgesia in patients undergoing forearm or hand surgery with a supraclavicular brachial plexus block, who receive either iv dexmedetomidine or placebo.
详细描述
Most surgical interventions on the forearm and the hand in Valais Hospital are performed under regional anesthesia. This ensures intraoperative patient comfort and reduces pain during the first 6 to 12 postoperative hours. A very common strategy to provide anesthesia of the arm is to inject local anesthetics in the region over the clavicle around the brachial plexus. This "supraclavicular brachial plexus block" is routinely performed in Valais Hospital and is always done under ultrasound guidance.
A drawback of locoregional anesthesia is the recurrence of pain once the effect of the block wears off after approximately 6 to 8 hours. This phenomenon is called rebound pain. It and can be very severe and debilitating, can significantly impact postoperative recovery and may also preclude ambulatory surgery as well as early mobilization and physiotherapy. Therefore, strategies that prolong the analgesic effect of locoregional anesthesia are warranted.
Dexmedetomidine is a selective α2-adrenoceptor agonists with sedative and analgesic properties. It has been shown to prolong the analgesic duration of local anesthetics when administered intravenously. However, the association of dexmedetomidine with long-acting local anesthetics for supraclavicular brachial plexus block has not been systematically investigated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
dexmedetomidine or placebo prepared by Lausanne University Hospital Pharmacy
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elbow, forearm or hand surgery under supraclavicular brachial plexus block Patients who are ASA physical status I-III
- •Exclusion criteria
- •Patient refusal
- •ASA physical status IV
- •History of hypersensitivity or intolerance to dexmedetomidine
- •History of hypersensitivity or intolerance to dexamethasone
- •History of hypersensitivity or intolerance to local anesthetics
- •History of recent (< 1 year) cerebrovascular insult
- •Second or third degree heart block
- •Uncontrolled hypotension
- •Conditions contraindicating supraclavicular brachial plexus block: neurological deficit or neuropathy of the arm, severe hepatic dysfunction (Child B and C), coagulopathy, malignancy or infection in the area above the clavicle
- •Chronic opioid use
- •Pregnancy
排除标准
- 未提供
研究组 & 干预措施
intravenous dexmedetomidine
Patients will receive intravenous dexmedetomidine 1 mcg/kg just after the supraclavicular brachial plexus block is completed
干预措施: Dexmedetomidine (Drug)
Placebo
Patients will receive intravenous placebo (normal saline) just after the supraclavicular brachial plexus is completed
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
duration of analgesia
时间窗: 24 hours on day of surgery
time in minutes from end of injection of local anesthetic till first analgesic request
次要结局
- Duration of sensory block(24 hours on day of surgery)
- Duration of motor block(24 hours on day of surgery)
- Patient satisfaction(7 days postoperatively)
- Total number of dexmedetomidine-related side effects(24 hours postoperatively)
- Dexmedetomidine-related side effects(24 hours postoperatively)
- Opioid-related side effect(24 hours postoperatively)
- Pain scores at rest(4, 24, 48 hours postoperatively)
- Pain scores on movement(4, 24, 48 hours postoperatively)
- Cumulative amount of opiate analgesic medication consumed(24, 48 hours postoperatively)