Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain
Overview
- Phase
- Not Applicable
- Intervention
- normal saline (placebo)
- Conditions
- Amputation
- Sponsor
- University of California, San Diego
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Brian M. Ilfeld, MD, MS
Associate Professor, In Residence
University of California, San Diego
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •known hepatic or renal insufficiency
- •allergy to the study medications
- •possessing a contraindication to perineural catheter placement or perineural local anesthetic infusion
Arms & Interventions
Placebo
3-7 days of perineural normal saline infusion
Intervention: normal saline (placebo)
Active
3-7 days of perineural local anesthetic infusion
Intervention: perineural ropivacaine
Outcomes
Primary Outcomes
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
Time Frame: Week 4
Secondary Outcomes
- 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)