Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Primary Analysis Will Compare the Two Treatment Groups for the Phantom Limb/Stump Pain Change From Baseline to 4 Weeks Following the Initial Catheter Placement
研究概览
简要总结
The purpose of this research study is to determine if putting local anesthetic-or numbing medication-through one or two tiny tube(s) placed next to the nerves that go to an amputated limb will decrease phantom limb and/or stump pain.
详细描述
Specific Aim 1: To determine if, compared with current standard-of-care treatment, the addition of an ambulatory continuous peripheral nerve block decreases post-amputation phantom limb and stump pain.
Hypothesis 1: Following upper or lower extremity amputation, phantom limb and/or stump pain will be significantly decreased four weeks following a multiple-day ambulatory continuous peripheral nerve block as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).
Specific Aim 2: To investigate the possible relationship between the addition of a multiple-day ambulatory continuous peripheral nerve block to standard-of-care treatment of post-amputation phantom limb and/or stump pain and cortical reorganization.
Hypothesis 2: Following upper or lower extremity amputation with subsequent phantom limb pain/sensation and/or stump pain, the addition of a multiple-day ambulatory continuous peripheral nerve block to standard-of-care treatment will result in cortical reorganization during and four-weeks following the perineural infusion (as measured by MRI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- 否
入选标准
- •previous upper or lower limb amputation including at least one metacarpal or metatarsal bone, respectively
- •age 18 years or older
- •phantom limb and/or stump pain described as at least a 2 on the NRS for the previous week [and pain occurring on a weekly basis over the previous month]
- •willing to have an ambulatory perineural infusion for 6 days
- •willing to avoid additional "new" analgesic interventions from 4 weeks prior to at least 4 weeks following catheter placement, and preferably to 6 months following catheter placement
- •the availability of a "caretaker" who will transport the subject home following the procedure and remain with the subject for the first night of the infusion
排除标准
- •known hepatic or renal insufficiency
- •allergy to the study medications
- •possessing a contraindication to perineural catheter placement or perineural local anesthetic infusion
研究组 & 干预措施
Placebo
3-7 days of perineural normal saline infusion
干预措施: normal saline (placebo) (Drug)
Active
3-7 days of perineural local anesthetic infusion
干预措施: perineural ropivacaine (Drug)
结局指标
主要结局
Primary Analysis Will Compare the Two Treatment Groups for the Phantom Limb/Stump Pain Change From Baseline to 4 Weeks Following the Initial Catheter Placement
时间窗: Week 4
次要结局
- Emotional Functioning · Beck Depression Inventory(pre-intervention; and then day 28 and 365 post-intervention)
- Nervous System Reorganization [if Patient Elected to Participate in the MRI Procedures] · MRI Procedure(pre-intervention; and then 8 and 28 days post-intervention)
- Pain · 11-point Numeric Rating Scale of Pain Intensity · Usage of Baseline and Rescue Analgesics in Previous 24 Hours · Patient Global Impression of Change Scale(Day 8, Day 28, Month 12)
- Physical Functioning · Brief Pain Inventory(pre-intervention, then days 1, 3, 8, 28, 84, and 365)
研究者
Brian M. Ilfeld, MD, MS
Associate Professor, In Residence
University of California, San Diego