Amputation, Phantom Limb, Stump Pain
Conditions
Keywords
pain, phantom limb, stump pain, catheter, nerve block, peripheral nerve block, ucsd, Post-amputation phantom limb or stump pain
Brief summary
Research study 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).
Interventions
PROCEDUREperineural ropivacaine
Subjects will be randomized to one of two groups: ropivacaine 0.4% or normal saline (placebo). The basal rate will be set at 7 mL/h.
Sponsors
Summit Medical
National Institute of General Medical Sciences (NIGMS)
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Week 4 |
Secondary
| Measure | Time frame |
|---|---|
| Physical Functioning · Brief Pain Inventory | pre-intervention, then days 1, 3, 8, 28, 84, and 365 |
| 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 |
Countries
United States
Outcome results
None listed