An interventional study of perineural ropivacaine and normal saline (placebo) in Amputation, Phantom Limb and Stump Pain, sponsored by University of California, San Diego. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-13.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
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).
150 studies on the registry are indexed under Phantom Limb; 40 are open to participants now.
This study's enrollment of 2 is below the median of 28 across 115 interventional studies indexed under Phantom Limb.
Browse Phantom Limb studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
3-7 days of perineural local anesthetic infusion
Drug: perineural ropivacaine
3-7 days of perineural normal saline infusion
Drug: normal saline (placebo)
ropivacaine 0.4%; the basal rate will be set at 7 mL/h
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
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.
| Milestone | Active | Placebo |
|---|---|---|
| Started | 1 | 1 |
| Completed | 0 | 0 |
| Not completed | 1 | 1 |
| Withdrew: Research coordinator didn't collect data | 1 | 1 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active | — | 0/1 (0%) | 0/1 (0%) |
| Placebo | — | 0/1 (0%) | 0/1 (0%) |
| Age, Categorical(Participants) | Active | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 2 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Active | Placebo | Total |
|---|---|---|---|
| Mean | 24 (24 to 24) | 23 (23 to 23) | 23.5 (23.5 to 23.5) |
| Sex: Female, Male(Participants) | Active | Placebo | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 1 | 1 | 2 |
| Region of Enrollment(Participants) | Active | Placebo | Total |
|---|---|---|---|
| United States | 1 | 1 | 2 |
This study is terminated, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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University of California, San Diego