RecruitingPhase 3

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

Canada1,602 participantsStarted 2021-09-22

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

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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

What they're measuring

Development of persistent pain 3-months after breast cancer surgery

Timeframe: 3- months

Trial details

NCT IDNCT04874038

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-01

Contact for this trial

James Khan

416-340-4800 James.Khan@medportal.ca

View on ClinicalTrials.gov More Post-mastectomy Pain Syndrome trials