The Efficacy and Safety of Dexmedetomidine as an Additive to Ropivacaine for Interscalene Brachial Plexus Blocks for Shoulder Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Efficacy of dexmedetomidine in perineural application
研究概览
简要总结
The purpose of this study is to test the efficacy and safety of dexmedetomidine added to ropivacaine in patients undergoing shoulder surgery.
详细描述
Peripheral nerve blocks are used throughout the world in lieu of general anesthesia and, more commonly, to provide analgesia and opioid sparing in the postoperative course. Long acting local anesthetics, such as ropivacaine, can provide analgesia for 11.5 ± 5 hours. This leads to many patients reporting their first pain in the evening and nighttime hours when access to healthcare providers and support is most limited. A number of additives to local anesthetics have been studied in humans with limited success. Recent work by a group in Michigan found a dose dependent increase in the duration of analgesia to a thermal stimulus when dexmedetomidine was added to ropivacaine for sciatic nerve blocks in rat.
The goal of the study is to investigate the safety and efficacy of dexmedetomidine added to ropivacaine for interscalene brachial plexus nerve block for shoulder surgery in humans. Provided the initial safety can be established, the trial will continue to evaluate secondary goals including the duration of analgesia, onset of sensory and motor blockade, and opioid-induced side effects. Tertiary outcomes will include subject satisfaction.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-III adult subjects
- •Age 18-75
- •Elective shoulder surgery
- •Plan for interscalene brachial plexus block combined with general anesthesia
- •Interscalene block
- •Willingness to be contacted postoperatively for brief (5-10min) phone call questionnaires
- •Written informed consent
排除标准
- •Age < 18
- •Age > 75
- •Inability to understand protocol due to language barrier; difficulty with German language
- •Chronic pain requiring daily opioids > 15 mg oral morphine equivalents (equals oral usage of > 10 mg oxycodone/daily; > 5 mg methadone/day; > 4 mg hydromorphone/day)
- •Moderate (NRS pain score > 5) daily average pain
- •Daily use of gabapentin, pregabalin, tricyclic antidepressant, serotonin- norepinephrine reuptake inhibitor, tramadol
- •Hypersensitivity to amide local anesthetics
- •History of hypersensitivity or allergic reaction to clonidine or dexmedetomidine
- •Uncontrolled anxiety
- •Schizophrenia or bipolar disorder
- •Preexisting nerve damage (sensory or motor) in the extremity to be blocked
- •Peripheral neuropathy
- •Significant cardiovascular disease (second (Mobitz II type) or third degree heart block, congestive heart failure, chronic heart failure NYHA III-IV, symptomatic coronary artery disease CSS III-IV)
- •BMI > 35
- •Uncontrolled diabetes (blood sugar > 250 recorded in last 30 days or HbA1c > 7.5%)
- •Chronic clonidine therapy (clonidine patch - Catapres or clonidine tablets)
- •Hepatic Impairment (CHILD B or higher)
- •Renal Impairment (creatinin > 2.0 mg/dl)
- •Ongoing drug or alcohol abuse
- •Pregnancy
- •Prisoners
研究组 & 干预措施
ropivacaine + dexmedetomidine
This group represents the standard of care drug (ropivacaine) plus the new additive to be studied (dexmedetomidine)
干预措施: dexmedetomidine (Drug)
ropivacaine + saline
This group represents the current standard of care in peripheral nerve blockade
干预措施: saline (Drug)
结局指标
主要结局
Efficacy of dexmedetomidine in perineural application
时间窗: 24 hrs
The time until the patient describes the blockade as completely gone will be analysed and compared between the groups.
Safety of dexmedetomidine in perineural application
时间窗: 30 days
Any serious and/or unexpected adverse (AE) events will be assessed on an individual basis by the Principal Investigator and the DSMB. After the first twenty subjects (10 controls and 10 receiving study agent) have completed the study, the data will be reviewed. Provided the DSMB determines the initial safety is established, enrollment will proceed until a total of 62 subjects (31 subjects/group) have been accrued.
次要结局
- Analgesia(first 24-48 hrs)
- Onset of sensory blockade(every 3 minutes for the first 21 minutes)
- Duration of motor blockade(first 24-48 hrs)
- Opioid-induced side effects(first 24-48 hrs)
研究者
Prof. Peter Gerner, M.D.
Professor
Paracelsus Medical University