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

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

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.

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Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    18 and up

Critères de participation

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)

Lieu de l'étude

Foothills Medical Centre
Foothills Medical Centre
Calgary, Alberta
Canada

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Primary Contact

May Lynn Quan, MD

Juravinski Hospital
Juravinski Hospital
Hamilton, Ontario
Canada

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Primary Contact

James Paul, MD

Humber River Hospital
Humber River Hospital
Toronto, Ontario
Canada

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Primary Contact

Sinziana Avramescu, MD

University Health Network
University Health Network
Toronto, Ontario
Canada

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Primary Contact

Hance Clarke, MD

IWK
IWK
Halifax, Nova Scotia
Canada

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Primary Contact

Allana Munro, MD

Thunder Bay Regional Health Sciences Centre
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario
Canada

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Primary Contact

Sudhakar Subramaniam Bharathidasan, MD

Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Toronto, Ontario
Canada

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Primary Contact

Stephen Choi, MD

Sturgeon Community Hospital
Sturgeon Community Hospital
Edmonton, Alberta
Canada

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Primary Contact

Simone Derzi, MD

North York General Hospital
North York General Hospital
North York, Ontario
Canada

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Primary Contact

Brian Pinchuk, MD

Mount Sinai Hospital
Mount Sinai Hospital
Toronto, Ontario
Canada

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Primary Contact

James Khan, MD

Women's College Hospital
Women's College Hospital
Toronto, Ontario
Canada

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Primary Contact

Richard Brull, MD

Eastern Health- Health Sciences Centre
Eastern Health- Health Sciences Centre
St. John's, Newfoundland and Labrador
Canada

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Primary Contact

Geoff Zbitnew, MD

The Ottawa Hospital
The Ottawa Hospital
Ottawa, Ontario
Canada

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Primary Contact

Daniel McIsaac, MD

St. Michael's Hospital
St. Michael's Hospital
Toronto, Ontario
Canada

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Primary Contact

Karim Ladha, MD

Hôpital Maisonneuve-Rosemont
Hôpital Maisonneuve-Rosemont
Montréal, Quebec
Canada

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Primary Contact

Philippe Richebe, MD

Étude parrainée par
University Health Network, Toronto
Participants recherchés
Plus d'informations
ID de l'étude: NCT04874038