Naval Medical Center San Diego (NMCSD) - Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain
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|ClinicalTrials.gov Identifier: NCT00768248|
Recruitment Status : Terminated (No longer enrolling patients, not enough enrollment)
First Posted : October 8, 2008
Last Update Posted : September 14, 2011
|Condition or disease||Intervention/treatment||Phase|
|Amputation Phantom Limb Stump Pain||Drug: perineural ropivacaine Drug: normal saline (placebo)||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|