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Using lidocaine infusions to prevent persistent pain after breast cancer surgery

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

Phase 3 Interventional University Health Network, Toronto · NCT04874038

This study is testing if giving lidocaine through an IV during breast cancer surgery can help prevent long-lasting pain afterward for patients.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1602 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorUniversity Health Network, Toronto Academic / other
Locations17 sites (Calgary, Alberta and 16 other locations)
Trial IDNCT04874038 on ClinicalTrials.gov

What this trial studies

This Phase III, international multicentre trial aims to evaluate the effectiveness of intravenous lidocaine infusions in reducing the incidence of persistent pain three months following breast cancer surgery. A total of 1,602 patients will be randomly assigned to receive either lidocaine or a placebo during their surgical procedure. The study will monitor patients for pain levels, analgesic use, and quality of life at multiple follow-up points, including three days, three months, and twelve months post-surgery. The trial is designed to provide robust data on the potential benefits of lidocaine in managing postoperative pain.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older undergoing unilateral or bilateral lumpectomy or mastectomy.

Not a fit: Patients with a history of chronic pain disorders at the surgical site or those with certain cardiac conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the occurrence of chronic pain in breast cancer surgery patients.

How similar studies have performed: Previous studies have shown promising results with lidocaine infusions in managing postoperative pain, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion 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)

Where this trial is running

Calgary, Alberta and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Post-mastectomy Pain SyndromeBreast CancerPain, PostoperativePain, Chronic
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.