Analgesia After Total Shoulder Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Numeric Rating Scale (NRS) Pain Score With Movement
研究概览
简要总结
The purpose of this study is to determine which medication(s) should be included in the interscalene nerve block (an injection of local anesthetic [numbing medicine] near nerves in the shoulder) for patients undergoing total shoulder arthroplasty (shoulder replacement). The ideal nerve block would reduce pain after shoulder surgery without causing a great deal of muscle weakness.
详细描述
All patients will receive an intravenous pain pump (patient-controlled analgesia) and a nerve block with long-lasting local anesthetic. The three study groups will receive additives (clonidine, dexamethasone, buprenorphine plus local anesthetic) in the nerve block that may reduce postoperative pain. One of the study groups uses the usual concentration of local anesthetic, while the other two study groups use reduced concentrations of local anesthetic. Follow-up with study patients begins on the day of surgery and continues through postoperative day 2. Seen twice daily, patients will be asked about their pain and assessed for sensory function and strength of their shoulder muscle and hand grip.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with osteoarthritis
- •Primary total shoulder arthroplasty
- •Age 18 to 80 years old
- •Planned use of general anesthesia
- •Planned use of a brachial plexus nerve block for postoperative analgesia
- •Ability to follow study protocol
排除标准
- •Patients younger than 18 years old and older than 80
- •Allergy or intolerance to one of the study medications
- •Patients with an American Society of Anesthesiologists (ASA) physical status of IV
- •Patients with insulin-dependent diabetes
- •Patients with hepatic (liver) failure
- •Patients with chronic renal (kidney) failure
- •Bradycardia (heart rate < 50) or hypotension (systolic blood pressure < 90 mmHg)
- •Chronic opioid use (taking opioids for longer than 3 months) (or active diagnosis of complex regional pain syndrome [CRPS]/reflex sympathetic dystrophy [RSD])
- •Lack of English fluency
结局指标
主要结局
Numeric Rating Scale (NRS) Pain Score With Movement
时间窗: 24 hours after the interscalene block is given
Pain with movement at 24 hours from the nerve block (scale of 0-10; 0 = no pain, 10 = worst possible pain)
次要结局
- Duration of Analgesia From Interscalene Nerve Block(Postoperative day 1 at 8AM & 5PM, postoperative day 2 at 8AM & 5PM)
- Numeric Rating Scale (NRS) Pain Scores at Rest(Preop)
- Middle Deltoid(24 hours after surgery)