Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- The primary outcome measurement will be the difference in average NRS (as administered as part of the Brief Pain Inventory) at 4 weeks between the two treatment groups.
研究概览
简要总结
The purpose of this research study is to determine if putting local anesthetic through one or two percutaneous catheters placed next to the nerves that go to an amputated limb will decrease long-term pain in the amputated limb.
详细描述
Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of multiple-day ambulatory continuous peripheral nerve blocks decrease the incidence and severity of post-amputation phantom limb and stump pain.
Hypothesis 1: Following upper or lower extremity amputation, the incidence of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment.
Hypothesis 2: Following upper or lower extremity amputation, the severity of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •undergoing unilateral surgical amputation of the upper or lower extremity including at least one metacarpal or metatarsal bone, respectively
- •currently without phantom limb and/or stump pain in a previously-amputated limb
- •ages 18 years or older
- •desiring perineural infusion for up to 6 days
- •willing to have an ambulatory infusion following hospital discharge
排除标准
- •hepatic or renal failure
- •allergy to the study medications
- •pregnancy
- •incarceration
- •possessing a contraindication to perineural catheter placement or perineural local anesthetic infusion
研究组 & 干预措施
1. standard care
1 day of perineural ropivacaine 0.2% infusion followed by 4-5 days of normal saline infusion.
干预措施: perineural ropivicaine (Procedure)
2: experimental care
4-5 days of perineural ropivacaine 0.4% infusion.
干预措施: perineural ropivicaine (Procedure)
结局指标
主要结局
The primary outcome measurement will be the difference in average NRS (as administered as part of the Brief Pain Inventory) at 4 weeks between the two treatment groups.
时间窗: Week 4
次要结局
- Pain and Physical functioning: Brief Pain Inventory (includes the 11-point numeric rating scale of pain intensity)(Preoperative, then days 3, 8, 28, 84, and 365)
- Emotional Functioning: Beck Depression Inventory(Preoperative, then days 28 and 365)
- The incidence of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment.(4 weeks)
研究者
Brian M. Ilfeld, MD, MS
Associate Professor, In Residence
University of California, San Diego