Liposomal Bupivacaine in Ambulatory Hand Surgery
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Post-operative Opioid Use
研究概览
简要总结
This study is being done to evaluate pain management regimens following ambulatory hand surgery. Improved pain control may be associated with decreased complications, decreased pain scores, decreased opioid dependence, improved patient comfort and satisfaction, and reduced healthcare costs. Liposomal bupivacaine is an FDA-approved local anesthetic. There will be two groups. One group will receive liposomal bupivacaine. One group will not. The results will be compared.
Patients will be over the age of 18 ambulatory hand surgery. Approximately 40 subjects will participate in this study at LLU.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age and over undergoing ambulatory hand surgery involving soft tissue and subfascial structures, including: CMC arthritis, flexor and extensor tendon injury, symptomatic ganglia, hand and finger fractures
排除标准
- •Patients who are unable to give informed consent to participate in this study
- •Patients with a documented history of hypersensitivity reactions to local anesthetic agents
- •Patients with a diagnosis of chronic pain disorders such as fibromyalgia, chronic migraine headaches, or psychiatric disorders other than depression or anxiety
- •Patients who are currently pregnant
- •Patients with impaired hepatic function
- •Patients with underlying nerve damage or impairment
- •Patients with renal impairment/failure
- •Patients whose career/livelihood require a great deal of hand dexterity, in whom a complication could cause a significant impact on life and career (ex: musician, dentist)
研究组 & 干预措施
Experimental Group
Patients in Group 2 (Liposomal Bupivacaine + Plain Bupivacaine) will be treated intra-operatively with the initial injection of 0.25% bupivacaine 5 - 10 mL (12.5 - 25 mg) delivered to perform a field block of the soft tissue and subfascial plane at the initiation of the procedure.
干预措施: Liposomal Bupivicaine (Drug)
结局指标
主要结局
Post-operative Opioid Use
时间窗: At scheduled intervals up to 168 hours post-operatively
Patients will record their opioid use post-operatively
次要结局
未报告次要终点
研究者
Subhas Gupta, MD, PhD
Chair of the Department of Plastic Surgery
Loma Linda University