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Recruiting NCT04874038

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

Phase III Interventional Post-mastectomy Pain Syndrome Breast Cancer Pain, Postoperative Pain, Chronic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lidocaine 20mg/ml, Placebo.
Who it may be relevant to
Registry conditions: Post-mastectomy Pain Syndrome, Breast Cancer, Pain, Postoperative, Pain, Chronic. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada, Nepal, Nigeria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

PLAN is a multicentre, parallel-group, blinded, randomized controlled trial of 1,602 patients undergoing breast cancer surgery. Consented eligible patients will be randomized to receive an intravenous lidocaine: 1.5 mg/kg bolus with induction of general anesthesia followed by a 2.0 mg/kg/hour infusion until the end of surgery (and up to 30 minutes into recovery room). Patients in the control group will receive a placebo bolus and infusion with normal saline (0.9% sodium chloride solution). Study medications will be prepared in blinded 50 mL syringes and labelled as per Regulatory requirements. Patients will follow up on the first 3 days after surgery, and at 3 and 12-months postoperatively to report on pain, analgesic consumption, functional, mood, and quality of life outcomes

Interventions

  • Drug Lidocaine 20mg/ml
    Patients in the intervention group will receive an IV lidocaine infusion using a dosage regimen of 1.5 mg/kg bolus of a 2% lidocaine solution with induction of general anesthesia followed by a 2.0 mg/kg/hour infusion until the end of surgery (and up to 30 minutes into recovery room).
  • Drug Placebo
    Patients in the control group will receive a placebo bolus and infusion with normal saline (0.9% sodium chloride solution) until the end of surgery (and up to 30 minutes into recovery room).

Primary outcome measures

  • Development of persistent pain 3-months after breast cancer surgery [Time frame: 3- months]
Secondary outcome measures (11)
  • Pain intensities [Time frame: 3 and 12 months]
  • Opioid consumption [Time frame: 3 and 12 months]
  • Moderate-to-severe persistent pain [Time frame: 3 and 12 months]
  • Persistent neuropathic pain [Time frame: 3 and 12 months]
  • Sensory and affective qualities of pain [Time frame: 3 and 12 months]
  • Emotional functioning [Time frame: 3 and 12 months]
  • Physical functioning [Time frame: 3 and 12 months]
  • Health-related quality of life quality of life [Time frame: 3 and 12 months]
  • Cancer Recurrence [Time frame: 3 and 12 months]
  • Adverse events [Time frame: 3 and 12 months]
  • Cost Effectiveness [Time frame: 3 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Canada · 15 centers
  • Foothills Medical Centre — Calgary
  • Sturgeon Community Hospital — Edmonton
  • Eastern Health- Health Sciences Centre — St. John's
  • IWK — Halifax
  • Juravinski Hospital — Hamilton
  • North York General Hospital — North York
  • The Ottawa Hospital — Ottawa
  • Thunder Bay Regional Health Sciences Centre — Thunder Bay
  • … and 7 more centers
Nepal · 1 center
  • B.P. Koirala Institute of Health Sciences — Dharān
Nigeria · 1 center
  • Obafemi Awolowo University Teaching Hospitals Complex — Ile-Ife

Publications

  • Khan JS, Gilron I, Devereaux PJ, Clarke H, Ayach N, Tomlinson G, Quan ML, Ladha KS, Choi S, Munro A, Brull R, Lim DW, Avramescu S, Richebe P, Hodgson N, Paul J, McIsaac DI, Derzi S, Zbitnew GL, Easson AM, Siddiqui NT, Miles SJ, Karkouti K; PLAN Trial Investigators. Prevention of persistent pain with lidocaine infusions in breast cancer surgery (PLAN): study protocol for a multicenter randomized co PMID 38773653

Identifiers

NCT: NCT04874038 · 21-5021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗