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

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ClinicalTrials.gov Identifier: NCT04874038
Recruitment Status : Recruiting
First Posted : May 5, 2021
Last Update Posted : February 21, 2022
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University Health Network, Toronto

Brief 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.

Condition or disease Intervention/treatment Phase
Post-mastectomy Pain Syndrome Breast Cancer Pain, Postoperative Pain, Chronic Drug: Lidocaine 20mg/ml Drug: Placebo Phase 3

Detailed Description:
PLAN is a multicentre, parallel-group, blinded, randomized controlled trial of 1,150 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
Actual Study Start Date : September 22, 2021
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : December 1, 2024


Arm Intervention/treatment
Experimental: Intervention
Intraoperative intravenous lidocaine/placebo infusion
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).
Other Name: Lidocaine 2%

Placebo Comparator: Control
Intraoperative intravenous lidocaine/placebo infusion
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).
Other Name: 0.9% sodium chloride solution




Primary Outcome Measures :
  1. Development of persistent pain 3-months after breast cancer surgery [ Time Frame: 3- months ]
    Persistent pain at 3-months


Secondary Outcome Measures :
  1. Pain intensities [ Time Frame: 3 and 12 months ]
    Pain intensities measured on the Numeric Rating Scale (NSR) at rest and movement.

  2. Opioid consumption [ Time Frame: 3 and 12 months ]
    Morphine-equivalent opioid consumption

  3. Moderate-to-severe persistent pain [ Time Frame: 3 and 12 months ]
    Defined as persistent pain with an NRS pain score of ≥4 at rest 24-hours

  4. Persistent neuropathic pain [ Time Frame: 3 and 12 months ]
    Measured using the Douleur Neuropathique 4-symptoms interview

  5. Sensory and affective qualities of pain [ Time Frame: 3 and 12 months ]
    Quality of pain is reported using the Short Form McGill Pain Questionnaire

  6. Emotional functioning [ Time Frame: 3 and 12 months ]
    Emotional functioning is reported using the Profile of Mood States (POMS)

  7. Physical functioning [ Time Frame: 3 and 12 months ]
    Physical functioning measured by the interference scale of the Brief Pain Inventory-Short Form.

  8. Health-related quality of life quality of life [ Time Frame: 3 and 12 months ]
    Health-related quality of life will be assessed using EQ-5D-5L

  9. Cancer Recurrence [ Time Frame: 3 and 12 months ]
    Cancer recurrence will be assessed as a secondary outcome

  10. Adverse events [ Time Frame: 3 and 12 months ]
    Adverse Events will be monitored as a secondary safety outcome



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04874038


Contacts
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Contact: James Khan 416-340-4800 ext 3243 James.Khan@medportal.ca
Contact: Nour Ayach 416-340-4800 ext 4221 Nour.Ayach@uhn.ca

Locations
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Canada, Alberta
Foothills Medical Centre Not yet recruiting
Calgary, Alberta, Canada
Contact: Maylynn Quan, MD         
Misericordia Community Hospital Not yet recruiting
Edmonton, Alberta, Canada
Contact: David Olson, MD         
University of Alberta Hospital Not yet recruiting
Edmonton, Alberta, Canada
Canada, Ontario
Juravinski Hospital Recruiting
Hamilton, Ontario, Canada
Contact: James Paul, MD         
The Ottawa Hospital Not yet recruiting
Ottawa, Ontario, Canada
Contact: Daniel McIsaac, MD         
Humber River Hospital Not yet recruiting
Toronto, Ontario, Canada
Contact: Sinziana Avramescu, MD         
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada
Contact: James Khan, MD         
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada
Contact: Karim Ladha, MD         
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada
Contact: Stephen Choi, MD         
University Health Network Recruiting
Toronto, Ontario, Canada
Contact: Hance Clarke, MD         
Women's College Hospital Not yet recruiting
Toronto, Ontario, Canada
Contact: Richard Brull, MD         
Canada, Quebec
Hôpital Maisonneuve-Rosemont Not yet recruiting
Montréal, Quebec, Canada
Contact: Philippe Richebe, MD         
Sponsors and Collaborators
University Health Network, Toronto
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: James Khan, MD University Health Network, Toronto
Principal Investigator: PJ Devereaux, MD.PhD Population Health Research Institute
Principal Investigator: Ian Gilron, MD Kingston Health Sciences Centre
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04874038    
Other Study ID Numbers: 21-5021
First Posted: May 5, 2021    Key Record Dates
Last Update Posted: February 21, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Pain, Postoperative
Chronic Pain
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action