Идёт набор NCT07274254

Lidocaine for Opioid Sparing in Vaso-occlusive Crisis of Sickle Cell Disease

Фаза III С лечением Vaso-Occlusive Pain Episode in Sickle Cell Disease

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: Lidocain, Placebo, Standard of care.
Кому может быть актуально: Состояния в реестре: Vaso-Occlusive Pain Episode in Sickle Cell Disease. Базовые параметры: от 18 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: Франция, Guadeloupe
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The purpose of the study is to determine whether adding lidocaine to standard of care in pain management during severe vaso-occlusive crisis has an effect on the cumulative opioid consumption expressed as morphine milligram equivalent.

Вмешательства

Препарат Lidocain
Lidocaine hydrochloride 20 mg/mL, solution, 20 mL ampoule for IV administration (25 ampoules) Administration : parenteral route on peripheral or central venous catheter. - Bolus of 1.5 mg/kg bolus dur
Препарат Placebo
Placebo is 20 mL ampoules of sodium chloride (NaCl 0.9%) for injection Administration : parenteral route on peripheral or central venous catheter. * Bolus of 1.5 mg/kg bolus during 30 minutes, with a maxium dose of 180 mg (18mL) * Immediately followed by a continuous infusion of 1 mg/kg/h (max 120mg/h = 12mL/h) during 72 hours.
Препарат Standard of care
Standard of care

Первичные конечные точки

Cumulative parenteral opioid dose between randomization and discharge from the intensive care unit expressed in morphine milligram equivalent. [Срок оценки: up to 28 days]

Вторичные конечные точки (12)

Intensive Care Unit length of stay [Срок оценки: up to 28 days]
hospital length of stay [Срок оценки: up to 28 days]
Visual analogue pain Scale score during Intensive Care Unit stay [Срок оценки: up to 28 days]
Categorical Pain Score during Intensive Care Unit stay [Срок оценки: up to 28 days]
Time of resolution of severe vaso-occlusive crisis [Срок оценки: up to 28 days]
time to last parenteral opioid dose [Срок оценки: up to 28 days]
vaso-occlusive crisis complications during Intensive Care Unit stay [Срок оценки: up to 28 days]
vaso-occlusive crisis complications during Intensive Care Unit stay [Срок оценки: up to 28 days]
vaso-occlusive crisis complications during Intensive Care Unit stay [Срок оценки: up to 28 days]
vaso-occlusive crisis complications during Intensive Care Unit stay [Срок оценки: up to 28 days]
quality of life with reduced impact of Sickle Cell Disease on health [Срок оценки: At Day 28]
safety profile of lidocaine infusion [Срок оценки: at 28 days]

Критерии участия

Критерии включения

Age >= 18 years
Known sickle cell disease with an SS, SC, Sβ, or Sβ+ genotype
Patient admitted to the Intensive Care Unit for Vaso-Occlusive Crisis and/or ACS as the main reason for admission:

Vaso-Occlusive Crisis defined by acute pain or tenderness, affecting at least one part of the body, including limbs, ribs, sternum, head (skull), spine, and/or pelvis, not attributable to other causes
Acute Chest Syndrome defined by the association of clinical respiratory sign(s): dyspnea and/or chest pain and/or auscultatory abnormality (crepitants and/or bronchial breathing) with a new pulmonary infiltrate on chest X-ray, thoracic CT-scan, or lung ultrasound.
Treatment with parenteral morphine or oxycodone started less than 72 hours prior to inclusion
Patient or next of kin informed about the study and having consented to the participation of the patient in the study. If patient is no competent and no next of kin can be contacted during screening for the study, trial inclusion will be completed as an emergency procedure by the Intensive Care Unit physician, in compliance with French law.
French speaking
Patient with health care insurance

Критерии исключения

Pregnant women or nursing mothers; Women of child bearing potential will be tested for pregnancy before inclusion
Patients under guardianship, curatorship or under legal protection
Prisoners or subjects who are involuntarily incarcerated
Sickle Cell Disease acute complication other than Vaso-Occlusive Crisis or Acute Chest Syndrome as the main reason for admission:

priapism, stroke, acute splenic sequestration, acute hepatic sequestration, bone marrow necrosis…

Patients wearing a lidocaine-medicated plaster at the time of screening for inclusion
Known or assumed hypersensitivity to lidocaine hydrochloride, other local anaesthetics (e.g., bupivacaine or ropivacaine) or an excipient
Patients treated with anti-arhythmic drugs known to induce torsade de pointe.
Patients on chronic or occasional treatment with drugs that interact with the 3A cytochrome isoenzymes (CYP3A) and/or 1A2 cytochrome isoenzymes (CYP1A2)
Patients with recurrent porphyria, porphyria in remission, or known asymptomatic carriage of gene mutations responsible for porphyria
Epileptic patients
Hypovolemic shock or shock of other cause at screening for inclusion
Known atrioventricular block, QT prolongation or other heart conduction disorder or heart failure
Chronic respiratory failure with long term non invasive ventilation (excluding Continuous Positive Air way pressure), or long term oxygen therapy at home
Acute Respiratory Distress Syndrome according to The 2012 Berlin definition
Acute or Chronic liver failure with MELD > 19 according to CKD-EPI
Acute or Chronic kidney failure with clearance <30mL/min/m2
Body weight <40kg and >120kg
Prior inclusion in the study in the last 3 months
Patient under invasive mechanical ventilation
Altered consciousness with Glasgow coma scale <13

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет