Optimization of Catheter Insertion Site for Continuous Peripheral Nerve Blocks
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Surgical pain as measured on a 0-10 scale where 0=no pain and 10=worst imaginable pain. The values for the two different catheter locations will be compared to see which site is optimal for catheter placement.
研究概览
简要总结
This research study is to determine if the insertion site of a perineural catheter or tiny tube placed next to the nerves that go to the part of the body (hand or arm) having surgery, affects the amount of pain relief that is experienced after surgery. Catheters will be placed in either the supraclavicular or infraclavicular location.
详细描述
To determine if a particular perineural local anesthetic catheter location (supraclavicular or infraclavicular) will maximize postoperative analgesia, minimize oral opioid requirements, minimize sleep disturbances resulting from postoperative pain, and maximize patient 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
- None
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
- •18 years of age or older
- •unilateral, upper (at or distal to the elbow) extremity orthopedic surgery with moderate-to-severe postoperative pain expected
- •patients already agree to and want a continuous brachial plexus block for postoperative analgesia
排除标准
- •patients who have difficulty understanding the study protocol or caring for the infusion pump/catheter system
- •patients who have any known contraindication to study medications
- •insulin-dependent diabetes mellitus
- •neuropathy of any etiology in the affected extremity
- •contraindication to regional blockade (e.g. clotting deficiency)
- •any known acute or chronic hepatic or renal insufficiency or failure
- •any incision site outside of the catheter-effected area
- •chronic opioid use
- •history of opioid abuse
- •pregnancy
- •incarceration
- •inability to communicate with the investigators and hospital staff
研究组 & 干预措施
1. Supraclavicular
Patients will be randomized to placement of a nerve block in the supraclavicular position. After the catheter has been placed, sensory and motor deficit will be assessed and following surgery, for the next three days, the patient will be contacted by research staff to assess pain scores and other outcome measures.
干预措施: Supraclavicular vs. Infraclavicular ropivicaine infusion (Procedure)
2. Infraclavicular
Patients will be randomized to placement of a nerve block in the infraclavicular position. After the catheter has been placed, sensory and motor deficit will be assessed and following surgery, for the next three days, the patient will be contacted by research staff to assess pain scores and other outcome measures.
干预措施: Supraclavicular vs. Infraclavicular ropivicaine infusion (Procedure)
结局指标
主要结局
Surgical pain as measured on a 0-10 scale where 0=no pain and 10=worst imaginable pain. The values for the two different catheter locations will be compared to see which site is optimal for catheter placement.
时间窗: 3 days
次要结局
- Opioids consumed by patient each day after surgery as reported to study staff.(3 days)
- Sleeping disturbances (difficulty sleeping and awakenings due to pain) as reported to the study staff.(3 days)
- Infusion side effects (shortness of breath) as reported to study staff.(3 day)
- Satisfaction with pain control as measured on a 0-10 scale where 0=very unsatisfied and 10=very satisfied, as reported to study staff at time of daily phone calls(3 days)
- Sensory and motor deficits (ability to move fingers and numbness of fingers) as reported to study staff.(3 days)
- Catheter site discomfort, leakage at catheter site, and catheter related pain on the 0-10 rating scale, where 0=no pain and 10=worst imaginable pain, as reported to study staff during phone calls.(3 days)