Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity Health Network, Toronto
About this trial
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
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Lidocaine 20mg/ml
- Placebo
Treatment groups
1,602 Participants
are divided into 2 treatment groupsSponsors and collaborators
University Health Network, Toronto
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov