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No longer enrolling patients, not enough enrollment
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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.
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 |
|
| Placebo | Placebo Comparator | 3-7 days of perineural normal saline infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| perineural ropivacaine | Drug | ropivacaine 0.4%; the basal rate will be set at 7 mL/h |
| |
| 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 | |
| Emotional Functioning · Beck Depression Inventory | pre-intervention; and then day 28 and 365 post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Hanling, M.D. | United States Naval Medical Center, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center San Diego | San Diego | California | 92134 | United States |
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Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected [coordinator simply did not collect the data] and so this pilot study was closed without producing results.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | 3-7 days of perineural local anesthetic infusion perineural ropivacaine: ropivacaine 0.4%; the basal rate will be set at 7 mL/h |
| FG001 | Placebo | 3-7 days of perineural normal saline infusion normal saline (placebo): the basal rate will be set at 7 mL/h |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| normal saline (placebo) |
| Drug |
the basal rate will be set at 7 mL/h |
|
| Nervous System Reorganization [if Patient Elected to Participate in the MRI Procedures] · MRI Procedure | 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 | Day 8, Day 28, Month 12 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | 3-7 days of perineural local anesthetic infusion perineural ropivacaine: ropivacaine 0.4%; the basal rate will be set at 7 mL/h |
| BG001 | Placebo | 3-7 days of perineural normal saline infusion normal saline (placebo): the basal rate will be set at 7 mL/h |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected [coordinator simply did not collect the data] and so this pilot study was closed without producing results. | Posted | Week 4 |
|
| |||||||||||||||||||||||
| Secondary | Physical Functioning · Brief Pain Inventory | Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected [coordinator simply did not collect the data] and so this pilot study was closed without producing results. | Posted | pre-intervention, then days 1, 3, 8, 28, 84, and 365 |
|
| |||||||||||||||||||||||
| Secondary | Emotional Functioning · Beck Depression Inventory | Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected [coordinator simply did not collect the data] and so this pilot study was closed without producing results. | Posted | pre-intervention; and then day 28 and 365 post-intervention |
|
| |||||||||||||||||||||||
| Secondary | Nervous System Reorganization [if Patient Elected to Participate in the MRI Procedures] · MRI Procedure | Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected [coordinator simply did not collect the data] and so this pilot study was closed without producing results. | Posted | pre-intervention; and then 8 and 28 days post-intervention |
|
| |||||||||||||||||||||||
| Secondary | 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 | Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected [coordinator simply did not collect the data] and so this pilot study was closed without producing results. | Posted | Day 8, Day 28, Month 12 |
|
|
not collected: Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected [coordinator simply did not collect the data] and so this pilot study was closed without producing results.
Recruitment failed at this center (NMCSD)--two subject were enrolled but they did not have data collected [coordinator simply did not collect the data] and so this pilot study was closed without producing results.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active | 3-7 days of perineural local anesthetic infusion perineural ropivacaine: ropivacaine 0.4%; the basal rate will be set at 7 mL/h | 0 | 1 | 0 | 1 | ||
| EG001 | Placebo | 3-7 days of perineural normal saline infusion normal saline (placebo): the basal rate will be set at 7 mL/h | 0 | 1 | 0 | 1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Ilfeld, MD, MS | University California San Diego | 858-822-0776 | bilfeld@ucsd.edu |
| ID | Term |
|---|---|
| D010591 | Phantom Limb |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| >=65 years |
|
| Male |
|