Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
Active, not recruitingPhase 3NCT04874038
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Brief summary (from the registry)
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.
Study details
- Official title
- Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
- Conditions
- Post-mastectomy Pain Syndrome
- Breast Cancer
- Pain, Postoperative
- Pain, Chronic
- Interventions
- Drug: Lidocaine 20mg/ml
- Drug: Placebo
- Sponsor
- University Health Network, Toronto
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Start date
- 2021-09-22
- Primary completion
- 2026-04-30
- Sex
- All
- Age range
- from 18 Years to 100 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada, Nepal, Nigeria
- Total sites listed
- 17
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Canadian sites (15)
| Facility | City | Province |
|---|---|---|
| Foothills Medical Centre | Calgary | Alberta |
| Sturgeon Community Hospital | Edmonton | Alberta |
| Eastern Health- Health Sciences Centre | St. John's | Newfoundland and Labrador |
| IWK | Halifax | Nova Scotia |
| Juravinski Hospital | Hamilton | Ontario |
| North York General Hospital | North York | Ontario |
| The Ottawa Hospital | Ottawa | Ontario |
| Thunder Bay Regional Health Sciences Centre | Thunder Bay | Ontario |
| Humber River Hospital | Toronto | Ontario |
| Mount Sinai Hospital | Toronto | Ontario |
| St. Michael's Hospital | Toronto | Ontario |
| Sunnybrook Health Sciences Centre | Toronto | Ontario |
| University Health Network | Toronto | Ontario |
| Women's College Hospital | Toronto | Ontario |
| Hôpital Maisonneuve-Rosemont | Montreal | Quebec |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04874038