Exparel (Bupivacaine Liposome Injectable Suspension) for Distal Upper Extremity Blocks in Orthopedic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Onset of Sensorimotor Block
研究概览
简要总结
The purpose of this study is to compare Exparel, a new, long-lasting numbing medication and a shorter-acting nerve block to a traditional single-shot nerve block in patients having hand, wrist or finger surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients 18 years or older having hand, wrist, or finger surgery
- •ability to understand and provide informed consent
- •American Society of Anesthesiologists status I-III
- •presence of a responsible adult caregiver for 48-72 hours after surgery
排除标准
- •patient refusal or inability to provide informed consent
- •true allergy, not sensitivity to local anesthetics, midazolam, fentanyl, hydromorphone, propofol
- •pregnancy
- •hepatic or renal failure
- •evidence of infection at or near the proposed needle insertion site
- •any sensorimotor deficit of the upper extremity
- •BMI greater than or equal to 35
- •uncontrolled or severe pulmonary disease
- •anticoagulant use (not aspirin or non-steroidal anti-inflammatories)
- •chronic pain patients
研究组 & 干预措施
Exparel forearm block
Under ultrasound guidance, 3-5 milliliters (mL) Exparel will be injected around the 3 nerves of the forearm prior to surgery. 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.
干预措施: Exparel Forearm block (Drug)
Bupivacaine supraclavicular block
Under ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block.
干预措施: Bupivacaine supraclavicular block (Drug)
结局指标
主要结局
Onset of Sensorimotor Block
时间窗: 30 minutes
A blinded study staff member will evaluate the subject after the block is performed. Subjects will be asked to move their hand and will be asked if they can feel a sharp sensation on specific areas of their hand. Once no movement and no feeling is detected, the block is considered successful and the time will be noted.
次要结局
未报告次要终点
研究者
Jose Soberon, MD
Anesthesiologist
Ochsner Health System