2024-518437-28-00招募中3 期
Lidocaine for opioid sparing in vaso-occlusive crisis of Sickle Cell Disease
Centre Hospitalier Universitaire De Nantes11 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2025年11月5日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 11
- 主要终点
- Cumulative parenteral opioid dose between randomisation and discharge from the intensive care unit expressed in morphine milligram equivalent. Only parenteral morphine and parenteral oxycodone will be taken in account, as tramadol and codein are weak opioids, and stronger opioids like fentanyl or sufentanyl are not likely to be used for spontaneously breathing patients.
研究概览
简要总结
To determine whether adding lidocaine to standard of care in pain management during sever vaso-occlusive crisis has an effect on the cumulative opioid consumption expressed as morphine milligram equivalent (MME).
研究设计
- 分配方式
- Randomized
- 主要目的
- Overall Trial
- 盲法
- Double (Analyst, Subject, Carer, Monitor, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Known sickle cell disease with an SS, SC, Sβ0, or Sβ+ genotype
- •Patient admitted to the intensive care unit for vaso-occlusive crisis and/or acute chest syndrome 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 cause / 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 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
排除标准
- •Pregnant women or nursing mothers; Women of child bearing potential will be tested for pregnancy before inclusion
- •Prior inclusion in the study in the last 3 months
- •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
- •Patient under invasive mechanical ventilation
- •Epileptic patients
- •Altered consciousness with Glasgow coma scale <13
- •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
结局指标
主要结局
Cumulative parenteral opioid dose between randomisation and discharge from the intensive care unit expressed in morphine milligram equivalent. Only parenteral morphine and parenteral oxycodone will be taken in account, as tramadol and codein are weak opioids, and stronger opioids like fentanyl or sufentanyl are not likely to be used for spontaneously breathing patients.
Cumulative parenteral opioid dose between randomisation and discharge from the intensive care unit expressed in morphine milligram equivalent. Only parenteral morphine and parenteral oxycodone will be taken in account, as tramadol and codein are weak opioids, and stronger opioids like fentanyl or sufentanyl are not likely to be used for spontaneously breathing patients.
次要结局
- Intensive care unit length of stay, in days, from randomisation
- Hospital length of stay, in days, from randomisation
- Visual Analogue pain Scale score and Categorical Pain Score score during intensive care unit stay
- Time from randomisation to vaso-occlusive crisis resolution, defined as presence of at least three of the following four criteria: continuous apyrexia for the last 8 hours, no need for intravenous opioid infusion for the last 8 hours, ability to walk or move without pain, and absence of spontaneous pain with a Categorical Pain Scale ≤1
- Time from randomisation to the last parenteral opioid dose
- Frequency of vaso-occlusive crisis complications: a) secondary acute chest syndrome (i.e. acute chest syndrome occurring after randomisation), b) need for blood transfusion, c) need for red blood cell exchange, d) need for life-supporting therapies defined as invasive mechanical ventilation or dialysis or vasopressor support
- Score of French version of Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) at D28
- Frequency of any adverse events and frequency of serious adverse events at D28
- Frequency of re-admissions in hospital (medicine ward or intensive care unit) or emergency-room visits by D28
- Incremental cost-effectiveness ratio (cost par Quality-Adjusted Life-Year, QALY) comparing lidocaine + standard of care to standard of care alone
研究者
Maïté AGBAKOU
Scientific
Centre Hospitalier Universitaire De Nantes
研究点 (11)
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