NCT04874038 is a Phase 3 clinical trial of Lidocaine 20mg/ml in Post-mastectomy Pain Syndrome, sponsored by University Health Network, Toronto.

Who is sponsoring NCT04874038?

NCT04874038 is sponsored by University Health Network, Toronto.

What drugs are being tested in NCT04874038?

Interventions in NCT04874038: Lidocaine 20mg/ml, Placebo.

What condition does NCT04874038 study?

NCT04874038 studies Post-mastectomy Pain Syndrome, Breast Cancer, Pain, Postoperative, Pain, Chronic.

Is NCT04874038 still recruiting?

NCT04874038 is currently recruiting now. Last updated 17 November 2025.

Last reviewed 2025-11-17 · How we verify

NCT04874038

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 3 Last updated 17 November 2025

What this trial tests

Phase 3 trial testing Lidocaine 20mg/ml in Post-mastectomy Pain Syndrome in 1,602 participants. Currently enrolling.

Timeline

22 September 2021

Primary endpoint
1 March 2026

1 November 2026

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	1,602
Start date	22 September 2021
Primary completion	1 March 2026
Estimated completion	1 November 2026
Sites	17 locations across Canada, Nigeria, Nepal

Drugs / interventions tested

Lidocaine 20mg/ml — full drug profile →
Placebo

Conditions studied

Post-mastectomy Pain Syndrome — all drugs for Post-mastectomy Pain Syndrome →
Breast Cancer — all drugs for Breast Cancer →
Pain, Postoperative — all drugs for Pain, Postoperative →
Pain, Chronic — all drugs for Pain, Chronic →

Sponsor

University Health Network, Toronto

Who can join

Adults 18 to 100, any sex, with Post-mastectomy Pain Syndrome or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Non-opioid analgesics for the prevention of chronic postsurgical pain: a systematic review and network meta-analysis.
Doleman B, Mathiesen O, Sutton AJ, Cooper NJ, et al · · 2023 · cited 36× · PMID 37059625 · DOI 10.1016/j.bja.2023.02.041
Prevention of persistent pain with lidocaine infusions in breast cancer surgery (PLAN): study protocol for a multicenter randomized controlled trial.
Khan JS, Gilron I, Devereaux PJ, Clarke H, et al · · 2024 · PMID 38773653 · DOI 10.1186/s13063-024-08151-4

Verify or expand the search:

Other trials of Lidocaine 20mg/ml

Trials testing the same drug.

NCT06446960 — The Role of Peripheral Afferents in Modulating Post-stroke Central Pain · Phase 3 · recruiting

Other University Health Network, Toronto trials

Trials by the same sponsor.

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NCT07515651 — Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas · Phase 2 · not yet recruiting
NCT07509450 — Fecal Microbiota Transplantation in Patients Undergoing Chimeric Antigen Receptor T-cell Therapy and Allogeneic Stem Cel · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04874038 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Health Network, Toronto
Last refreshed: 17 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04874038.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing