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NCT03461120 · ClinicalTrials.gov registry record · Phase 4
Improving Postamputation Functioning by Decreasing Phantom Pain With Perioperative Continuous Peripheral Nerve Blocks: A Department of Defense Funded Multicenter Study
A Phase 4 study of Post-amputation Phantom Limb Pain and Lower Extremity Surgical Amputation, sponsored by University of California, San Diego.
- Active
- Registry status
- Phase 4
- Development phase
- 203
- Enrollment target
- 8
- Study locations
NCT03461120: Active Phase 4 study of Post-amputation Phantom Limb Pain and Lower Extremity Surgical Amputation, sponsored by University of California, San Diego.
NCT03461120 is a Phase 4 study of Post-amputation Phantom Limb Pain and Lower Extremity Surgical Amputation that is active but no longer recruiting, run by University of California, San Diego. The registered enrollment target is 203 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower). The trial reports 8 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03461120, a Phase 4 study of Post-amputation Phantom Limb Pain and Lower Extremity Surgical Amputation, is active but no longer recruiting, sponsored by University of California, San Diego.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 203 participants
- Enrollment target
- 8
- Study locations
Study Summary
When a limb is amputated, pain perceived in the part of the body that no longer exists often develops, called "phantom limb" pain. The exact reason that phantom limb pain occurs is unclear, but when a nerve is cut-as happens with an amputation-changes occur in the brain and spinal cord that are associated with persistent pain. The negative feedback-loop between the injured limb and the brain can be stopped by putting local anesthetic-called a "nerve block"-on the injured nerve, effectively keeping any "bad signals" from reaching the brain. A "continuous peripheral nerve block" (CPNB) is a technique providing pain relief that involves inserting a tiny tube-smaller than a piece of spaghetti-through the skin and next to the target nerve. Local anesthetic is then introduced through the tiny tube, which bathes the nerve in the numbing medicine. This provides a multiple-day block that provides opioid-free pain control with no systemic side effects, and may prevent the destructive feedback loop that results in phantom limb pain following an amputation. We propose a multicenter, randomized, triple-masked (investigators, subjects, statisticians), placebo-controlled, parallel arm, human-subjects clinical trial to determine if a prolonged, high-concentration (dense), perioperative CPNB improves post-amputation physical and emotional functioning while decreasing opioid consumption, primarily by preventing chronic phantom limb pain.
Primary Outcome
comprised of 14 items, all scored on a 5-point ordinal scale. Each question inquires about the ability and level of independence when performing a specific activity. There are two subscales comprised of 7 questions each evaluating basic and advanced abilities, but the primary end point of the current study will involve the total score that includes both activity levels.
Conditions Studied
Interventions
- DRUG Experimental continuous peripheral nerve blocks
- DRUG Control continuous peripheral nerve blocks
Study Locations (8)
Massachusetts
- Mass. General Hospital - Boston
- Brigham and Women's Hospital - Boston
- Boston VA - Boston
California
- University California San Diego - San Diego
- Naval Medical Center San Diego - San Diego
Ohio
- Fairview Hospital - Cleveland
- Cleveland Clinic - Cleveland
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2018-03-23 |
| Est. Completion | 2026-11-18 |
| Phase | Phase 4 |
What the registry record for NCT03461120 still lists
NCT03461120 is an interventional study that assigns participants to a tested intervention. The registered 203 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower).
The record links to 2 conditions, with Post-amputation Phantom Limb Pain appearing as the primary indexed condition, and to 2 interventions - of which Experimental continuous peripheral nerve blocks is the first listed.
NCT03461120 lists 8 locations in 4 states (Massachusetts, California, Ohio).
Frequently Asked Questions
What is clinical trial NCT03461120 about?
NCT03461120 is a clinical study titled "Improving Postamputation Functioning by Decreasing Phantom Pain With Perioperative Continuous Peripheral Nerve Blocks: A Department of Defense Funded Multicenter Study". When a limb is amputated, pain perceived in the part of the body that no longer exists often develops, called "phantom limb" pain. The exact reason that phantom limb pain occurs is unclear, but when a nerve is cut-as happens with an amputation-changes occur in the brain and spinal cord that are asso...
What is the current status of trial NCT03461120?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 203 participants. The study started on 2018-03-23. Estimated completion is 2026-11-18.
What conditions does trial NCT03461120 study?
This clinical trial studies the following conditions: Post-amputation Phantom Limb Pain, Lower Extremity Surgical Amputation.
What interventions are being tested in trial NCT03461120?
The interventions under investigation include: Experimental continuous peripheral nerve blocks (DRUG), Control continuous peripheral nerve blocks (DRUG).
Who is sponsoring clinical trial NCT03461120?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03461120 being conducted?
This trial has 8 study locations across California, Massachusetts, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03461120's enrollment target sits among peer trials
203 403rd of 2000 higher than 1,598 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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