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Could not secure funding to complete the study.
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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The purpose of this research study is to determine if putting local anesthetic through one or two percutaneous catheters placed next to the nerves that go to an amputated limb will decrease long-term pain in the amputated limb.
Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of multiple-day ambulatory continuous peripheral nerve blocks decrease the incidence and severity of post-amputation phantom limb and stump pain.
Hypothesis 1: Following upper or lower extremity amputation, the incidence of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment.
Hypothesis 2: Following upper or lower extremity amputation, the severity of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. standard care | Placebo Comparator | 1 day of perineural ropivacaine 0.2% infusion followed by 4-5 days of normal saline infusion. |
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| 2: experimental care | Active Comparator | 4-5 days of perineural ropivacaine 0.4% infusion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| perineural ropivicaine | Procedure | Subjects will be randomized to one of two groups: ropivicaine 0.2% infusion for days 0-1 then infusion with normal saline (placebo) for days 1 through catheter removal (POD 4 or 5) or ropivicaine 0.4% infusion for day 0 through catheter removal (POD 4 or 5). The infusion rate will be set at 7-11 mL/h. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measurement will be the difference in average NRS (as administered as part of the Brief Pain Inventory) at 4 weeks between the two treatment groups. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain and Physical functioning: Brief Pain Inventory (includes the 11-point numeric rating scale of pain intensity) | Preoperative, then days 3, 8, 28, 84, and 365 | |
| Emotional Functioning: Beck Depression Inventory | Preoperative, then days 28 and 365 |
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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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| The incidence of phantom limb and/or stump pain will be significantly decreased four weeks following multiple-day ambulatory continuous peripheral nerve blocks as compared with patients receiving standard-of-care treatment. | 4 weeks |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |