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Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Completion pushed from Nov 1, 2026 to May 1, 2027 · Enrollment target: estimated 1602 to confirmed 1604 · Interventions: Lidocaine 20mg/ml (Drug), Placebo (Drug) to Lidocaine 20mg/ml (Drug), Placebo (Drug) · 3 more Show 6 more changesShow less
    • Completion pushed from Nov 1, 2026 to May 1, 2027
    • Enrollment target: estimated 1602 to confirmed 1604
    • Interventions: Lidocaine 20mg/ml (Drug), Placebo (Drug) to Lidocaine 20mg/ml (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 11 words
    • Site details revised at 17 of 17 sites
    • Publications: details revised at 1 of 1 entry
  2. Primary completion date changed from estimate of Mar 1, 2026 to Apr 30, 2026v15
  3. Primary completion date: Jun 1, 2025 to Mar 1, 2026 Study sites: 16 to 17 · Completion date: Jun 1, 2026 to Nov 1, 2026v14 Show 2 more changesShow less
    • Study sites: 16 to 17
    • Completion date: Jun 1, 2026 to Nov 1, 2026
  4. Site details revised at 1 of 16 sitesv13
  5. Study sites: 15 to 16v12
Show 10 earlier versionsHide 10 earlier versions
  1. Study sites: 14 to 15v11
  2. Enrollment target: 1150 to 1602 Secondary endpoints: 10 to 11 · Study description revisedv10 Show 2 more changesShow less
    • Secondary endpoints: 10 to 11
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Jan 1, 2024 to Jun 1, 2025 Completion date: Dec 1, 2024 to Jun 1, 2026 · Site details revised at 1 of 14 sitesv9 Show 2 more changesShow less
    • Completion date: Dec 1, 2024 to Jun 1, 2026
    • Site details revised at 1 of 14 sites
  4. Study sites: 13 to 14v8
  5. Study sites revised (13)v7 See this version in full on ClinicalTrials.gov ↗
  6. Study sites: 12 to 13v6
  7. Site details revised at 7 of 12 sitesv5
  8. Study sites: 1 to 12v4
  9. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jul 26, 2021 to Sep 22, 2021v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 26, 2021 to Sep 22, 2021
  10. Start date: Jun 1, 2021 to Jul 26, 2021 Secondary endpoints: 9 to 10 · Eligibility criteria shortened, about 1 wordv2 Show 2 more changesShow less
    • Secondary endpoints: 9 to 10
    • Eligibility criteria shortened, about 1 word

    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.
Phase III, international multicentre, parallel group, blinded, 1:1 randomized controlled trial to determine the effect of an intraoperative intravenous lidocaine infusion on reducing the development of persistent pain 3-months after breast cancer surgery.
Trial Details
NCT Number NCT04874038
Lead Sponsor University Health Network, Toronto
Collaborators: Canadian Institutes of Health Research (CIHR)
Conditions Post-mastectomy Pain Syndrome, Breast Cancer, Pain, Postoperative, Pain, Chronic
Enrollment 1,604 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov