UCSD Medical Center
San Diego, California, 92103, United States
NCT Number: NCT00667264
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
San Diego, California, 92103, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Week 4
Time frame: pre-intervention, then days 1, 3, 8, 28, 84, and 365
Time frame: pre-intervention; and then 8 and 28 days post-intervention
Time frame: Day 8, Day 28, Month 12
University of California, San Diego
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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