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

Primary Purpose

Post-mastectomy Pain Syndrome, Breast Cancer, Pain, Postoperative

Status
Recruiting
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Lidocaine 20mg/ml
Placebo
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-mastectomy Pain Syndrome

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Foothills Medical CentreRecruiting
  • Sturgeon Community HospitalRecruiting
  • Eastern Health- Health Sciences CentreRecruiting
  • IWKRecruiting
  • Juravinski HospitalRecruiting
  • The Ottawa HospitalRecruiting
  • Humber River HospitalRecruiting
  • Mount Sinai HospitalRecruiting
  • St. Michael's HospitalRecruiting
  • Sunnybrook Health Sciences CentreRecruiting
  • University Health NetworkRecruiting
  • Women's College HospitalRecruiting
  • Hôpital Maisonneuve-RosemontRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

Intraoperative intravenous lidocaine/placebo infusion

Intraoperative intravenous lidocaine/placebo infusion

Outcomes

Primary Outcome Measures

Development of persistent pain 3-months after breast cancer surgery
Persistent pain at 3-months

Secondary Outcome Measures

Pain intensities
Pain intensities measured on the Numeric Rating Scale (NSR) at rest and movement.
Opioid consumption
Morphine-equivalent opioid consumption
Moderate-to-severe persistent pain
Defined as persistent pain with an NRS pain score of ≥4 at rest 24-hours
Persistent neuropathic pain
Measured using the Douleur Neuropathique 4-symptoms interview
Sensory and affective qualities of pain
Quality of pain is reported using the Short Form McGill Pain Questionnaire
Emotional functioning
Emotional functioning is reported using the Profile of Mood States (POMS)
Physical functioning
Physical functioning measured by the interference scale of the Brief Pain Inventory-Short Form.
Health-related quality of life quality of life
Health-related quality of life will be assessed using EQ-5D-5L
Cancer Recurrence
Cancer recurrence will be assessed as a secondary outcome
Adverse events
Adverse Events will be monitored as a secondary safety outcome

Full Information

First Posted
April 20, 2021
Last Updated
September 28, 2023
Sponsor
University Health Network, Toronto
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT04874038
Brief Title
Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
Official Title
Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 1,150 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-mastectomy Pain Syndrome, Breast Cancer, Pain, Postoperative, Pain, Chronic

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intraoperative intravenous lidocaine/placebo infusion
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Intraoperative intravenous lidocaine/placebo infusion
Intervention Type
Drug
Intervention Name(s)
Lidocaine 20mg/ml
Other Intervention Name(s)
Lidocaine 2%
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
0.9% sodium chloride solution
Intervention Description
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 Measure Information:
Title
Development of persistent pain 3-months after breast cancer surgery
Description
Persistent pain at 3-months
Time Frame
3- months
Secondary Outcome Measure Information:
Title
Pain intensities
Description
Pain intensities measured on the Numeric Rating Scale (NSR) at rest and movement.
Time Frame
3 and 12 months
Title
Opioid consumption
Description
Morphine-equivalent opioid consumption
Time Frame
3 and 12 months
Title
Moderate-to-severe persistent pain
Description
Defined as persistent pain with an NRS pain score of ≥4 at rest 24-hours
Time Frame
3 and 12 months
Title
Persistent neuropathic pain
Description
Measured using the Douleur Neuropathique 4-symptoms interview
Time Frame
3 and 12 months
Title
Sensory and affective qualities of pain
Description
Quality of pain is reported using the Short Form McGill Pain Questionnaire
Time Frame
3 and 12 months
Title
Emotional functioning
Description
Emotional functioning is reported using the Profile of Mood States (POMS)
Time Frame
3 and 12 months
Title
Physical functioning
Description
Physical functioning measured by the interference scale of the Brief Pain Inventory-Short Form.
Time Frame
3 and 12 months
Title
Health-related quality of life quality of life
Description
Health-related quality of life will be assessed using EQ-5D-5L
Time Frame
3 and 12 months
Title
Cancer Recurrence
Description
Cancer recurrence will be assessed as a secondary outcome
Time Frame
3 and 12 months
Title
Adverse events
Description
Adverse Events will be monitored as a secondary safety outcome
Time Frame
3 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Khan
Phone
416-340-4800
Ext
3243
Email
James.Khan@medportal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Nour Ayach
Phone
416-340-4800
Ext
4221
Email
Nour.Ayach@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Khan, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
PJ Devereaux, MD.PhD
Organizational Affiliation
Population Health Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ian Gilron, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
May Lynn Quan, MD
Facility Name
Sturgeon Community Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simone Derzi, MD
Facility Name
Eastern Health- Health Sciences Centre
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geoff Zbitnew, MD
Facility Name
IWK
City
Halifax
State/Province
Nova Scotia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allana Munro, MD
Facility Name
Juravinski Hospital
City
Hamilton
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Paul, MD
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel McIsaac, MD
Facility Name
Humber River Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sinziana Avramescu, MD
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Khan, MD
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim Ladha, MD
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Choi, MD
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hance Clarke, MD
Facility Name
Women's College Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Brull, MD
Facility Name
Hôpital Maisonneuve-Rosemont
City
Montréal
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Richebe, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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