Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
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| ClinicalTrials.gov Identifier: NCT04874038 |
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Recruitment Status :
Recruiting
First Posted : May 5, 2021
Last Update Posted : November 27, 2023
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Sponsor:
University Health Network, Toronto
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University Health Network, Toronto
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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 |
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
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intervention
Intraoperative intravenous lidocaine/placebo infusion
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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% |
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Placebo Comparator: Control
Intraoperative intravenous lidocaine/placebo infusion
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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 :
- Development of persistent pain 3-months after breast cancer surgery [ Time Frame: 3- months ]Persistent pain at 3-months
Secondary Outcome Measures :
- 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
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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:
- 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)
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
| 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
| Canada, Alberta | |
| Foothills Medical Centre | Recruiting |
| Calgary, Alberta, Canada | |
| Contact: May Lynn Quan, MD | |
| Sturgeon Community Hospital | Recruiting |
| Edmonton, Alberta, Canada | |
| Contact: Simone Derzi, MD | |
| Canada, Newfoundland and Labrador | |
| Eastern Health- Health Sciences Centre | Recruiting |
| St. John's, Newfoundland and Labrador, Canada | |
| Contact: Geoff Zbitnew, MD | |
| Canada, Nova Scotia | |
| IWK | Recruiting |
| Halifax, Nova Scotia, Canada | |
| Contact: Allana Munro, MD | |
| Canada, Ontario | |
| Juravinski Hospital | Recruiting |
| Hamilton, Ontario, Canada | |
| Contact: James Paul, MD | |
| The Ottawa Hospital | Recruiting |
| Ottawa, Ontario, Canada | |
| Contact: Daniel McIsaac, MD | |
| Thunder Bay Regional Health Sciences Centre | Not yet recruiting |
| Thunder Bay, Ontario, Canada | |
| Contact: Sudhakar Subramaniam Bharathidasan, MD | |
| Humber River Hospital | 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 | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Stephen Choi, MD | |
| University Health Network | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Hance Clarke, MD | |
| Women's College Hospital | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Richard Brull, MD | |
| Canada, Quebec | |
| Hôpital Maisonneuve-Rosemont | Recruiting |
| Montréal, Quebec, Canada | |
| Contact: Philippe Richebe, MD | |
Sponsors and Collaborators
University Health Network, Toronto
Canadian Institutes of Health Research (CIHR)
Investigators
| 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 |
| 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: | November 27, 2023 |
| Last Verified: | November 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |