Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
Recruiting · NCT04874038 · Interventional (participants receive a specific treatment) · Lead sponsor: University Health Network, Toronto
View the official record on ClinicalTrials.gov →Interventions studied
Lidocaine 20mg/mlPlacebo
What this trial is about
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.
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age ≥18 years old
- 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
- Previous breast surgery within 6 months of index surgery
- Undergoing any autologous flap procedure during index surgery
- Presence known chronic pain disorder involving surgical site or ipsilateral chest wall, shoulder, or arm during the 3-months prior to index surgery
- Documented hypersensitivity or allergy to lidocaine
- 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)
- History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker
- Known cirrhotic liver disease
- Pregnant
- 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)
Where it is running
17 locations listed.
- B.P. Koirala Institute of Health Sciences - Dharān, Nepal
- Obafemi Awolowo University Teaching Hospitals Complex - Ile-Ife, Nigeria
- Foothills Medical Centre - Calgary, Alberta, Canada
- Sturgeon Community Hospital - Edmonton, Alberta, Canada
- Eastern Health- Health Sciences Centre - St. John's, Newfoundland and Labrador, Canada
- IWK - Halifax, Nova Scotia, Canada
- Juravinski Hospital - Hamilton, Ontario, Canada
- North York General Hospital - North York, Ontario, Canada
- The Ottawa Hospital - Ottawa, Ontario, Canada
- Thunder Bay Regional Health Sciences Centre - Thunder Bay, Ontario, Canada
- Humber River Hospital - Toronto, Ontario, Canada
- Mount Sinai Hospital - Toronto, Ontario, Canada
- St. Michael's Hospital - Toronto, Ontario, Canada
- Sunnybrook Health Sciences Centre - Toronto, Ontario, Canada
- University Health Network - Toronto, Ontario, Canada
- Women's College Hospital - Toronto, Ontario, Canada
- Hôpital Maisonneuve-Rosemont - Montreal, Quebec, Canada