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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 : April 8, 2024
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE April 20, 2021
First Posted Date  ICMJE May 5, 2021
Last Update Posted Date April 8, 2024
Actual Study Start Date  ICMJE September 22, 2021
Estimated Primary Completion Date June 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2021)		 Development of persistent pain 3-months after breast cancer surgery [ Time Frame: 3- months ]
Persistent pain at 3-months
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2024)
  • Pain intensities [ Time Frame: 3 and 12 months ]
    Pain intensities measured on the Numeric Rating Scale (NSR) at rest and movement.
  • Opioid consumption [ Time Frame: 3 and 12 months ]
    Morphine-equivalent opioid consumption
  • 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
  • Persistent neuropathic pain [ Time Frame: 3 and 12 months ]
    Measured using the Douleur Neuropathique 4-symptoms interview
  • Sensory and affective qualities of pain [ Time Frame: 3 and 12 months ]
    Quality of pain is reported using the Short Form McGill Pain Questionnaire
  • Emotional functioning [ Time Frame: 3 and 12 months ]
    Emotional functioning is reported using the Profile of Mood States (POMS)
  • Physical functioning [ Time Frame: 3 and 12 months ]
    Physical functioning measured by the interference scale of the Brief Pain Inventory-Short Form.
  • 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
  • Cancer Recurrence [ Time Frame: 3 and 12 months ]
    Cancer recurrence will be assessed as a secondary outcome
  • Adverse events [ Time Frame: 3 and 12 months ]
    Adverse Events will be monitored as a secondary safety outcome
  • Cost Effectiveness [ Time Frame: 3 months ]
    Healthcare Costs associated with the burden of chronic post-surgical pain will be assessed
Original Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2021)
  • Pain intensities [ Time Frame: 3 and 12 months ]
    Pain intensities measured on the Numeric Rating Scale (NSR) at rest and movement.
  • Opioid consumption [ Time Frame: 3 and 12 months ]
    Morphine-equivalent opioid consumption
  • 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
  • Persistent neuropathic pain [ Time Frame: 3 and 12 months ]
    Measured using the Douleur Neuropathique 4-symptoms interview
  • Sensory and affective qualities of pain [ Time Frame: 3 and 12 months ]
    Quality of pain is reported using the Short Form McGill Pain Questionnaire
  • Emotional functioning [ Time Frame: 3 and 12 months ]
    Emotional functioning is reported using the Profile of Mood States (POMS)
  • Physical functioning [ Time Frame: 3 and 12 months ]
    Physical functioning measured by the interference scale of the Brief Pain Inventory-Short Form.
  • 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
  • Adverse events [ Time Frame: 3 and 12 months ]
    Adverse Events will be monitored as a secondary safety outcome
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
Official Title  ICMJE Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Post-mastectomy Pain Syndrome
  • Breast Cancer
  • Pain, Postoperative
  • Pain, Chronic
Intervention  ICMJE
  • 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%
  • 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
Study Arms  ICMJE
  • Experimental: Intervention
    Intraoperative intravenous lidocaine/placebo infusion
    Intervention: Drug: Lidocaine 20mg/ml
  • Placebo Comparator: Control
    Intraoperative intravenous lidocaine/placebo infusion
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 5, 2024)		 1602
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2021)		 1150
Estimated Study Completion Date  ICMJE June 1, 2026
Estimated Primary Completion Date June 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: James Khan 416-340-4800 ext 3243 James.Khan@medportal.ca
Contact: Nour Ayach 416-340-4800 ext 4221 Nour.Ayach@uhn.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04874038
Other Study ID Numbers  ICMJE 21-5021
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University Health Network, Toronto
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Health Network, Toronto
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: James Khan, MD University Health Network, Toronto
Principal Investigator: PJ Devereaux, MD.PhD Population Health Research Institute
Principal Investigator: Ian Gilron, MD Queen's University
PRS Account University Health Network, Toronto
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP