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NCT01824082 · ClinicalTrials.gov registry record · Phase 4
Treating Phantom Limb Pain Using Continuous Peripheral Nerve Blocks: A Department of Defense Funded Multicenter Study
A Phase 4 study of Phantom Limb Pain, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 4
- Development phase
- 144
- Enrollment target
- 4
- Study locations
NCT01824082 is a Phase 4 study of Phantom Limb Pain that has completed, run by University of California, San Diego. The registered enrollment target is 144 participants, above the 111-participant average among 12 other Phantom Limb Pain trials with a reported enrollment target (30% higher). The trial reports 4 study locations across 3 states.
The verdict
NCT01824082, a Phase 4 study of Phantom Limb Pain, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 144 participants
- Enrollment target
- 4
- Study locations
Study Summary
When a limb is traumatically severed, pain perceived in the part of the body that no longer exists often develops. This is called "phantom limb" pain, and is different from "stump" pain, which is pain within the part of the limb that remains intact. Unfortunately, phantom pain resolves in only 16% of people, with the rest experiencing this pain for the remainder of the lives. There is currently no reliable treatment for phantom limb pain. The exact reason that phantom limb pain occurs is unclear, but when a nerve is cut-as happens with a traumatic amputation-changes occur in the brain and spinal cord that actually worsen with increasing phantom pain. These abnormal changes may often be corrected by putting local anesthetic-termed a "peripheral nerve block"-on the injured nerve, keeping any "bad signals" from reaching the brain, with resolution of the phantom limb pain. However, when the nerve block ends after a few hours, the phantom pain returns. But, this demonstrates that the brain abnormalities-and phantom pain-that occur with an amputation may be dependent upon the "bad" signals being sent from the injured nerve(s), suggesting that a very long peripheral nerve block-lasting many days rather than hours-may permanently reverse the abnormal changes in the brain, and provide lasting relief from phantom pain. Until recently, extending a peripheral nerve block beyond 16 hours was unrealistic. However, a treatment option called a "continuous peripheral nerve block" is now available. This technique involves the placement of a tiny tube-smaller than a piece of spaghetti-through the skin and next to the nerves supplying the amputated limb. The tiny tube may be placed with minimal discomfort in about 15 minutes. Numbing medicine called local anesthetic is then infused through the tube, blocking any signals that the injured nerve sends to the spinal cord and brain. Using a small, portable infusion pump, this prolonged nerve block may be provided in individuals' own homes
Conditions Studied
Interventions
- DRUG Perineural infusion [continuous peripheral nerve block(s)]
Study Locations (4)
California
- Veteran's Affairs Palo Alto Health Care System - Palo Alto
- University of California, San Diego, Hillcrest Medical Center - San Diego
Maryland
- Walter Reed Army National Medical Center - Bethesda
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2013-12-01 |
| Est. Completion | 2020-10 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01824082
The ClinicalTrials.gov registry entry for NCT01824082 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 111-participant average among 12 other Phantom Limb Pain trials with a reported enrollment target (30% higher). The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Phantom Limb Pain appearing as the primary indexed condition, and to 1 intervention - of which Perineural infusion [continuous peripheral nerve block(s)] is the first listed.
NCT01824082 reports 4 study locations spanning 3 distinct geographic areas - top geographies include California, Maryland, Ohio.
Frequently Asked Questions
What is clinical trial NCT01824082 about?
NCT01824082 is a clinical study titled "Treating Phantom Limb Pain Using Continuous Peripheral Nerve Blocks: A Department of Defense Funded Multicenter Study". When a limb is traumatically severed, pain perceived in the part of the body that no longer exists often develops. This is called "phantom limb" pain, and is different from "stump" pain, which is pain within the part of the limb that remains intact. Unfortunately, phantom pain resolves in only 16% o...
What is the current status of trial NCT01824082?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 144 participants. The study started on 2013-12-01. Estimated completion is 2020-10.
What conditions does trial NCT01824082 study?
This clinical trial studies the following conditions: Phantom Limb Pain.
What interventions are being tested in trial NCT01824082?
The interventions under investigation include: Perineural infusion [continuous peripheral nerve block(s)] (DRUG).
Who is sponsoring clinical trial NCT01824082?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01824082 being conducted?
This trial has 4 study locations across California, Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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