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Improving Postamputation Functioning by Decreasing Phantom Pain With Perioperative Continuous Peripheral Nerve Blocks: A Department of Defense Funded Multicenter Study

StatusCompleted
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Study completion date changed from estimate of Nov 18, 2026 to Aug 18, 2026 · Enrollment target: estimated 203 to confirmed 208 · Eligibility criteria expanded, about 13 words · 4 more Show 7 more changesShow less
    • Study completion date changed from estimate of Nov 18, 2026 to Aug 18, 2026
    • Enrollment target: estimated 203 to confirmed 208
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 5 of 13 entries
    • Study description expanded, about 10 words
    • Site details revised at 1 of 8 sites
    • Collaborators: 9 to 7
  2. Trial status: Enrolling by Invitation to Active, Not Recruiting Primary completion date: Jun 2026 to Aug 18, 2026 · Completion date: Oct 2026 to Nov 18, 2026v21 Show 2 more changesShow less
    • Primary completion date: Jun 2026 to Aug 18, 2026
    • Completion date: Oct 2026 to Nov 18, 2026
  3. Completion date: Sep 2026 to Oct 2026 Study description expanded, about 163 wordsv20 Show 1 more changeShow less
    • Study description expanded, about 163 words

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Mar 2026 to Jun 2026 Completion date: Jun 2026 to Sep 2026v19 Show 1 more changeShow less
    • Completion date: Jun 2026 to Sep 2026
  5. Primary completion date: Aug 2025 to Mar 2026 Completion date: Aug 2026 to Jun 2026v18 Show 1 more changeShow less
    • Completion date: Aug 2026 to Jun 2026
Show 16 earlier versionsHide 16 earlier versions
  1. Primary completion date: Dec 2024 to Aug 2025 Completion date: Dec 2025 to Aug 2026v17 Show 1 more changeShow less
    • Completion date: Dec 2025 to Aug 2026
  2. Re-verified, no change to tracked fieldsv16
  3. Primary completion date: Dec 2022 to Dec 2024 Completion date: Dec 2023 to Dec 2025v15 Show 1 more changeShow less
    • Completion date: Dec 2023 to Dec 2025
  4. Re-verified, no change to tracked fieldsv14
  5. Primary completion date: Dec 2021 to Dec 2022 Enrollment target: 218 to 203 · Study sites: 4 to 8 · Completion date: Dec 2022 to Dec 2023 · 2 morev13 Show 5 more changesShow less
    • Enrollment target: 218 to 203
    • Study sites: 4 to 8
    • Completion date: Dec 2022 to Dec 2023
    • Collaborators: 7 to 9
    • Study description expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  6. Primary completion date: Sep 2021 to Dec 2021 Completion date: Sep 2022 to Dec 2022v12 Show 1 more changeShow less
    • Completion date: Sep 2022 to Dec 2022
  7. Re-verified, no change to tracked fieldsv11
  8. Primary completion date: Sep 2020 to Sep 2021 Completion date: Sep 2021 to Sep 2022v10 Show 1 more changeShow less
    • Completion date: Sep 2021 to Sep 2022
  9. Trial status: Recruiting to Enrolling by Invitation Site details revised at 4 of 4 sites · Collaborators: 8 to 7v9 Show 2 more changesShow less
    • Site details revised at 4 of 4 sites
    • Collaborators: 8 to 7

    See this version in full on ClinicalTrials.gov ↗

  10. Site details revised at 2 of 4 sitesv8
  11. Re-verified, no change to tracked fieldsv7
  12. Study title expanded, about 7 wordsv6 See this version in full on ClinicalTrials.gov ↗
  13. Study description expanded, about 46 wordsv5 See this version in full on ClinicalTrials.gov ↗
  14. Start date changed from estimate of Mar 20, 2018 to Mar 23, 2018v4
  15. Trial status: Not Yet Recruiting to Recruiting Study sites: 3 to 4 · Start date: Mar 2018 to Mar 20, 2018 · Study description revisedv3 Show 3 more changesShow less
    • Study sites: 3 to 4
    • Start date: Mar 2018 to Mar 20, 2018
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  16. Secondary endpoints: 10 to 13v2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03461120
Lead Sponsor University of California, San Diego
Collaborators: United States Department of Defense, United States Naval Medical Center, San Diego, The Cleveland Clinic, Walter Reed National Military Medical Center, Northwestern University, Massachusetts General Hospital, Brigham and Women's Hospital
Conditions Lower Extremity Surgical Amputation, Post-amputation Phantom Limb Pain
Enrollment 208 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov