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| ID | Type | Description | Link |
|---|---|---|---|
| GM077026 |
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| Name | Class |
|---|---|
| Summit Medical | UNKNOWN |
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | 3-7 days of perineural local anesthetic infusion |
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| Placebo | Placebo Comparator | 3-7 days of perineural normal saline infusion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| perineural ropivacaine | Procedure | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Functioning · Brief Pain Inventory | pre-intervention, then days 1, 3, 8, 28, 84, and 365 | |
| Nervous System Reorganization [if patient elected to participate in the MRI procedures] · MRI procedure | pre-intervention; and then 8 and 28 days post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Ilfeld, M.D., M.S. | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Medical Center | San Diego | California | 92103 | United States |
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| ID | Term |
|---|---|
| D010591 | Phantom Limb |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| 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 | Day 8, Day 28, Month 12 |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |