The Analgesic Effect of Dexmedetomidine as an Adjunct to Local Anesthetics in Ultrasound-guided Interscalene Approach to Brachial Plexus Block for Shoulder Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Duration of interscalene nerve block.
研究概览
简要总结
The purpose of this study is to determine whether a small dose of Dexmedetomidine, when given either intravenously or as part of the interscalene nerve block solution, prolongs pain relief following shoulder surgery compared to local anesthetic solution alone.
详细描述
Unilateral shoulder surgical procedures, including acromioplasty, rotator cuff repair and Bankart procedure generally allow the patient to go home the same day. However, post-surgical pain is often severe and it is common to encounter a delay in discharge from the hospital due to difficulty in pain control.
Single shot interscalene block is used in ambulatory shoulder surgery for its advantages that included a significant reduction in acute pain and analgesic requirements, prolonged time to first analgesic request, decreased incidence of nausea, as well as earlier hospital discharge. Previous studies have attempted to prolong the duration of the analgesia of interscalene block by administering additional drugs to the local anesthetics but these studies have had varying degrees of success. Dexmedetomidine has recently been considered as a potentially useful drug in prolonging nerve block analgesia. Various modes of administration of Dexmedetomidine have demonstrated a consistent effect on the duration of analgesia. So far, the systemic infusion of Dex has been shown to prolong both neuraxial and peripheral nerve blocks. When combined with local anesthetics in intravenous regional anesthesia 9IVRA), Dex enhanced the duration of analgesia. Furthermore, data from animal studies strongly support the use of Dex as a safe potent adjunct to local anesthetics capable of prolonging the duration of analgesia of peripheral nerve blocks.
The use of Dexmedetomidine as an adjunct in interscalene block has not been studied yet. This trial will study the effects of adding Dexmedetomidine as an adjunct to local anesthetics in interscalene brachial plexus 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unilateral surgical shoulder procedures under general anesthetic
- •English speaking patients
- •ASA I-III patients
- •BMI <38 kg/m2
排除标准
- •proximal clavicular surgery
- •preexisting neurological deficits or peripheral neuropathy
- •known coronary heart disease, congestive heart failure, cardiomyopathies, or arrhythmias
- •known cerebrovascular disease
- •baseline heart rate <60 beats per minute or baseline systolic blood pressure <100 mm Hg
- •medications that reduce heart rate (as beta-blockers, calcium blockers) known liver dysfunction or existing diseases known to cause hepatic or renal impairment
- •severe bronchopulmonary disease
- •local infection
- •contra-indication to regional anesthesia (bleeding, coagulopathy)
- •chronic pain disorders
- •current use of over 30mg oxycodone or equivalent per day
- •contraindication to a component of multimodal analgesia
- •allergy to local anesthetics or dexmedetomidine
- •history of significant psychiatric conditions that may affect patient assessment
- •pregnancy
- •inability to provide consent
研究组 & 干预措施
Ropivacaine,Normal Saline,Saline Bolus
Ropivacaine 15 mL 0.5% Normal Saline mL 0.9% Saline Bolus
干预措施: Ropivacaine (Drug)
Ropivacaine,Normal Saline,Saline Bolus
Ropivacaine 15 mL 0.5% Normal Saline mL 0.9% Saline Bolus
干预措施: Normal Saline (Drug)
Ropivacaine,Dexmedetomidine,Saline Bolus
Ropivacaine15 mL 0.5% Dexmedetomidine0.5 u/kg Saline Bolus
干预措施: Dexmedetomidine (Drug)
Ropivacaine,Dexmedetomidine,Saline Bolus
Ropivacaine15 mL 0.5% Dexmedetomidine0.5 u/kg Saline Bolus
干预措施: Ropivacaine (Drug)
Ropivacaine,Dexmedetomidine,Saline Bolus
Ropivacaine15 mL 0.5% Dexmedetomidine0.5 u/kg Saline Bolus
干预措施: Normal Saline (Drug)
Ropivacaine,Saline,Dexmedetomidine
Ropivacaine 15 mL 0.5% Normal Saline 1 mL 0.9% Dexmedetomidine single IV bolus 0.5 u/kg over 30 minutes
干预措施: Dexmedetomidine (Drug)
Ropivacaine,Saline,Dexmedetomidine
Ropivacaine 15 mL 0.5% Normal Saline 1 mL 0.9% Dexmedetomidine single IV bolus 0.5 u/kg over 30 minutes
干预措施: Ropivacaine (Drug)
Ropivacaine,Saline,Dexmedetomidine
Ropivacaine 15 mL 0.5% Normal Saline 1 mL 0.9% Dexmedetomidine single IV bolus 0.5 u/kg over 30 minutes
干预措施: Normal Saline (Drug)
结局指标
主要结局
Duration of interscalene nerve block.
时间窗: Duration of time is from the end of local anesthetic injection (interscalene block) to the onset of pain at the surgical site.
Opioid consumption
时间窗: Cumulative opioid consumption at 24 hours postoperatively
次要结局
- Opioid Consumption(Total use of opioids from the period of intra-operative to 2 weeks post-operative)