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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Intraoperative intravenous lidocaine/placebo infusion |
|
| Control | Placebo Comparator | Intraoperative intravenous lidocaine/placebo infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine 20mg/ml | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Development of persistent pain 3-months after breast cancer surgery | Persistent pain at 3-months | 3- months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensities | Pain intensities measured on the Numeric Rating Scale (NSR) at rest and movement. | 3 and 12 months |
| Opioid consumption | Morphine-equivalent opioid consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James Khan | Contact | 416-340-4800 | 3243 | James.Khan@medportal.ca |
| Nour Ayach | Contact | 416-340-4800 | 4221 | Nour.Ayach@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| James Khan, MD | University Health Network, Toronto | Principal Investigator |
| PJ Devereaux, MD.PhD | Population Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Recruiting | Calgary | Alberta | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38773653 | Derived | 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 controlled trial. Trials. 2024 May 22;25(1):337. doi: 10.1186/s13063-024-08151-4. |
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|
|
| Placebo | Drug | 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). |
|
|
| 3 and 12 months |
| Moderate-to-severe persistent pain | Defined as persistent pain with an NRS pain score of ≥4 at rest 24-hours | 3 and 12 months |
| Persistent neuropathic pain | Measured using the Douleur Neuropathique 4-symptoms interview | 3 and 12 months |
| Sensory and affective qualities of pain | Quality of pain is reported using the Short Form McGill Pain Questionnaire | 3 and 12 months |
| Emotional functioning | Emotional functioning is reported using the Profile of Mood States (POMS) | 3 and 12 months |
| Physical functioning | Physical functioning measured by the interference scale of the Brief Pain Inventory-Short Form. | 3 and 12 months |
| Health-related quality of life quality of life | Health-related quality of life will be assessed using EQ-5D-5L | 3 and 12 months |
| Cancer Recurrence | Cancer recurrence will be assessed as a secondary outcome | 3 and 12 months |
| Adverse events | Adverse Events will be monitored as a secondary safety outcome | 3 and 12 months |
| Cost Effectiveness | Healthcare Costs associated with the burden of chronic post-surgical pain will be assessed | 3 months |
| Ian Gilron, MD |
| Kingston Health Sciences Centre |
| Principal Investigator |
| Sturgeon Community Hospital | Recruiting | Edmonton | Alberta | Canada |
|
| Eastern Health- Health Sciences Centre | Recruiting | St. John's | Newfoundland and Labrador | Canada |
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| IWK | Recruiting | Halifax | Nova Scotia | Canada |
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| Juravinski Hospital | Recruiting | Hamilton | Ontario | Canada |
|
| North York General Hospital | Recruiting | North York | Ontario | Canada |
|
| The Ottawa Hospital | Recruiting | Ottawa | Ontario | Canada |
|
| Thunder Bay Regional Health Sciences Centre | Recruiting | Thunder Bay | Ontario | Canada |
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| Humber River Hospital | Recruiting | Toronto | Ontario | Canada |
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| Mount Sinai Hospital | Recruiting | Toronto | Ontario | Canada |
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| St. Michael's Hospital | Recruiting | Toronto | Ontario | Canada |
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| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | Canada |
|
| University Health Network | Recruiting | Toronto | Ontario | Canada |
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| Women's College Hospital | Recruiting | Toronto | Ontario | Canada |
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| Hôpital Maisonneuve-Rosemont | Recruiting | Montreal | Quebec | Canada |
|
| B.P. Koirala Institute of Health Sciences | Recruiting | Dharān | Nepal |
| Obafemi Awolowo University Teaching Hospitals Complex | Recruiting | Ile-Ife | Nigeria |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010149 | Pain, Postoperative |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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