Naval Medical Center San Diego (NMCSD) - Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain
|Amputation Phantom Limb Stump Pain||Drug: perineural ropivacaine Drug: normal saline (placebo)|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain|
- 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 ]
- Physical Functioning · Brief Pain Inventory [ Time Frame: pre-intervention, then days 1, 3, 8, 28, 84, and 365 ]
- Emotional Functioning · Beck Depression Inventory [ Time Frame: pre-intervention; and then day 28 and 365 post-intervention ]
- Nervous System Reorganization [if patient elected to participate in the MRI procedures] · MRI procedure [ Time Frame: 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 [ Time Frame: Day 8, Day 28, Month 12 ]
|Study Start Date:||October 2008|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Active
3-7 days of perineural local anesthetic infusion
Drug: perineural ropivacaine
ropivacaine 0.4%; the basal rate will be set at 7 mL/h
Placebo Comparator: Placebo
3-7 days of perineural normal saline infusion
Drug: normal saline (placebo)
the basal rate will be set at 7 mL/h
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00768248
|United States, California|
|Naval Medical Center San Diego|
|San Diego, California, United States, 92134|
|Principal Investigator:||Steven Hanling, M.D.||United States Naval Medical Center, San Diego|