Expired Study
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San Diego, California 92134


Purpose:

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.


Study summary:

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).


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


NCT ID:

NCT00768248


Primary Contact:

Principal Investigator
Steven Hanling, M.D.
United States Naval Medical Center, San Diego


Backup Contact:

N/A


Location Contact:

San Diego, California 92134
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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