Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Lidocaine 20mg/ml, Placebo.
- Кому может быть актуально
- Состояния в реестре: Post-mastectomy Pain Syndrome, Breast Cancer, Pain, Postoperative, Pain, Chronic. Базовые параметры: 18 лет — 100 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Канада, Nepal, Nigeria
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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
Вмешательства
- Препарат 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). - Препарат 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).
Первичные конечные точки
- Development of persistent pain 3-months after breast cancer surgery [Срок оценки: 3- months]
Вторичные конечные точки (11)
- Pain intensities [Срок оценки: 3 and 12 months]
- Opioid consumption [Срок оценки: 3 and 12 months]
- Moderate-to-severe persistent pain [Срок оценки: 3 and 12 months]
- Persistent neuropathic pain [Срок оценки: 3 and 12 months]
- Sensory and affective qualities of pain [Срок оценки: 3 and 12 months]
- Emotional functioning [Срок оценки: 3 and 12 months]
- Physical functioning [Срок оценки: 3 and 12 months]
- Health-related quality of life quality of life [Срок оценки: 3 and 12 months]
- Cancer Recurrence [Срок оценки: 3 and 12 months]
- Adverse events [Срок оценки: 3 and 12 months]
- Cost Effectiveness [Срок оценки: 3 months]
Критерии участия
Критерии включения
- 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)
Критерии исключения
- 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)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Профилактика
Центры проведения
Канада · 15 центров
- Foothills Medical Centre — Calgary
- Sturgeon Community Hospital — Edmonton
- Eastern Health- Health Sciences Centre — St. John's
- IWK — Halifax
- Juravinski Hospital — Hamilton
- North York General Hospital — North York
- The Ottawa Hospital — Ottawa
- Thunder Bay Regional Health Sciences Centre — Thunder Bay
- … и ещё 7 центров
Nepal · 1 центр
- B.P. Koirala Institute of Health Sciences — Dharān
Nigeria · 1 центр
- Obafemi Awolowo University Teaching Hospitals Complex — Ile-Ife
Публикации
- 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 co PMID 38773653
Идентификаторы
NCT: NCT04874038 · 21-5021