NCT04874038 Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
| NCT ID | NCT04874038 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Health Network, Toronto |
| Condition | Post-mastectomy Pain Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,602 participants |
| Start Date | 2021-09-22 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,602 participants in total. It began in 2021-09-22 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years old 2. Undergoing a unilateral or bilateral lumpectomy or mastectomy, inclusive of all pathologies, including prophylactic surgery (e.g., family history or BRCA gene mutation) Exclusion Criteria: 1. Previous breast surgery within 6 months of index surgery 2. Undergoing any autologous flap procedure during index surgery 3. Presence known chronic pain disorder involving surgical site or ipsilateral chest wall, shoulder, or arm during the 3-months prior to index surgery 4. Documented hypersensitivity or allergy to lidocaine 5. Surgery not planned to be performed under general anesthesia and/or planned use of regional or neuraxial anesthetic techniques before surgery (i.e., epidural, paravertebral, serratus plane block, pectoralis or modified pectoralis block) 6. History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker 7. Known cirrhotic liver disease 8. Pregnant 9. Unlikely to comply with follow-up (e.g. no fixed address, language difficulties that would impede valid completion of questionnaires, plans to move out of town)
Contact & Investigator
James Khan, MD
PRINCIPAL INVESTIGATOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT04874038 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Post-mastectomy Pain Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04874038 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,602 participants.
Is NCT04874038 currently recruiting?
Yes, NCT04874038 is actively recruiting participants. Contact the research team at James.Khan@medportal.ca for enrollment information.
Where is the NCT04874038 trial being conducted?
This trial is being conducted at Calgary, Canada, Edmonton, Canada, St. John's, Canada, Halifax, Canada and 11 additional locations.
Who is sponsoring the NCT04874038 clinical trial?
NCT04874038 is sponsored by University Health Network, Toronto. The principal investigator is James Khan, MD at University Health Network, Toronto. The trial plans to enroll 1,602 participants.