Amputation Clinical Trial
Official title:
Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain
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.
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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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