LIDOCRIT : Effect of Continuous Intravenous LIDOcaine on Discomfort in Postoperative CRITical Care Inpatients

Обзор

Although pain management in intensive care units and intensive care units has improved since the DOLOREA study, research into therapies and techniques to optimise analgesia is still needed. The many adverse effects of morphine are well known, and it has been observed that excessive sedation during the first 48 hours is associated with an increase in mortality and length of stay. Multimodal analgesia protocols, preferably including non-morphine analgesics, could improve the comfort of critical care patients. Comfort is a central element of critical care and perioperative management, as demonstrated by Patients-Reported Outcomes (PRO), new assessment tools that take into account the patient as a whole. The (Inconfort of REAnimation Patients) IPREA questionnaire, a specific scale for assessing the comfort of critical care patients, is an example of a PRO. Lidocaine is a voltage-dependent sodium channel blocker, used as a local anaesthetic and antiarrhythmic agent, whose intravenous administration produces analgesic effects, particularly on hyperalgesia. The widely demonstrated clinical benefits in scheduled and major surgery (reduced post-operative pain, reduced doses of anaesthetic agents and opiates, reduced post-operative nausea and vomiting) have led to recommendations for its use. Furthermore, adverse events associated with lidocaine in continuous infusion are minimal. Based on the early Comfort using Analgesia (eCASH), minimal Sedative and maximal Human care) concepts, the recent PADIS (Pain, Agitation, Delirium, Immobility, Sleep deprivation) recommendations, which determine levels of evidence and research avenues for improving the quality of care, conclude that intravenous lidocaine may be beneficial, but there is a lack of data. The investigators are therefore proposing a randomised placebo-controlled clinical trial to assess the effectiveness of lidocaine infused continuously for 48 hours on the perceived comfort of post-operative critical care patients, as assessed by the IPREA score. IPREA, an 18-item score exploring PADIS, is a direct, relevant, objective and reproducible assessment criterion for evaluating algorithms for improving the quality of care. The data on sources of discomfort reveal the importance of pain, dyspnoea, thirst and sleep deprivation, which are all influenced by the analgesia-sedation protocol. Incorporating lidocaine with anti-hyperalgesic properties into the protocol should reduce discomfort in critical care patients.

Подробное описание

The choice of analgesia protocol will be left to the discretion of the clinician between MORPHINE CHLORHYDRATE, SUFENTANIL and REMIFENTANIL for objectives of Behavioral Pain Scale (BPS) (3 to 5) or pain visual analogue scale (VAS) \< 4.

The use of co-analgesics intraoperatively (Paracetamol, Nefopam, NSAIDs (nonsteroidal anti-inflammatory drugs) such as Ketoprofen or Ibuprofen, Ketamine) is authorised (data not collected).

If a hypnotic is required intraoperatively, the choice of agent is left to the discretion of the clinician.

Once the sedation-analgesia protocol has been discontinued, pain relief is left to the clinician's discretion.

Patients are monitored from randomisation until discharge from the critical care unit or until a maximum of 30 days post-operatively.

In the event of an adverse reaction linked to lidocaine (see list in § 8.2.), the doctor stops administration of the product.

The blind is lifted (see § 9.2 'Insu (or blinding)'). If the patient is in the lidocaine group, the lidocaine plasma concentration is measured to check for a toxic plasma concentration (see § 5.6 'Management of biological samples').

It should be noted that the completion of an assay or discontinuation of treatment does not result in the patient's withdrawal from the clinical trial. Patient follow-up continues until the end of the trial.

If the patient is discharged from critical care before the 30th post-operative day, the patient's vital status on the 30th post-operative day will be collected.

Вмешательства

• Препарат Lidocaine (drug)
  Lidocaine 2%, bolus of 0.075 ml/kg real weight (i.e. 1.5 mg/kg) then IVSE at 0.05 ml/kg/h (i.e. 1 mg/kg/h) for 48 hours
• Препарат Placebo
  Placebo (sodium chloride 0.9%), bolus of 0.075 ml/kg of real weight then IVSE at 0.05 ml/kg/h for 48h

Первичные конечные точки

• IPREA [Срок оценки: Within 24 hours of discharge from critical care or, failing that, within 24 hours of the 15th day of hospitalisation in critical care.]

Вторичные конечные точки (12)

• IPREA - Sensitivity analysis of the main criterion [Срок оценки: Within 24 hours of discharge from critical care or, failing that, within 24 hours of the 15th day of hospitalisation in critical care.]
• IPREA [Срок оценки: Within 24 hours of discharge from critical care or, failing that, within 24 hours of the 7th day of hospitalisation in critical care]
• IPREA - 8 items [Срок оценки: Within 24 hours of discharge from critical care or, failing that, within 24 hours of the 15th day of hospitalisation in critical care.]
• Cumulative opioid consumption [Срок оценки: Over the first 6 post-surgery days]
• Duration of invasive mechanical ventilation [Срок оценки: Until discharge from critical care, including, in the event of transfer, the stay in critical care in the transfer hospital, or, failing this, until day 30]
• Occurrence of re-intubation [Срок оценки: Within 48 hours of extubation (until discharge from critical care, including, in the event of transfer, the stay in critical care in the transfer hospital, or, failing that, until day 30)]
• Duration of sedation [Срок оценки: Until discharge from critical care, including, in the event of transfer, the stay in critical care in the transfer hospital, or, failing this, until day 30]
• Duration of stay in critical care [Срок оценки: Until day 30]
• Duration of stay in hospital [Срок оценки: Until day 30]
• Occurrence of pneumonia [Срок оценки: During the stay in critical care, including, in the event of transfer, the stay in critical care in the transfer hospital, up to day 30]
• Vital status [Срок оценки: Day 30]
• Incidence of serious adverse reactions attributable to lidocaine [Срок оценки: For the duration of the treatment and 24 hours after the end of the treatment]

Критерии участия

Критерии включения

• Patient over 18
• Patient admitted immediately post-operatively in critical care (scheduled or emergency admission, e.g. post-operative exploratory laparotomy, cardiac surgery, major orthopaedic surgery such as polytrauma patients, vascular surgery at risk of complications such as open aortic surgery)
• Anticipated length of stay in critical care ≥ 48h
• Membership of a social security scheme
• Informed consent signed by the patient or by a close relative or legal representative or, failing this, the emergency procedure

Non-inclusion Criteria:

• Weight over 100 kg
• Hypersensitivity to one of the active substances used for anaesthesia or to one of the excipients.
• Known acute porphyria,
• Pregnant or breast-feeding women
• Patients who have received or are about to receive peri-medullary analgesia intra-operatively or post-operatively.
• Patient who has received or will receive loco-regional analgesia intra-operatively or post-operatively.
• Severe head injury, open cephalic neurosurgery, interventional neuroradiology
• Recovered cardiorespiratory arrest
• Noradrenaline doses > 0.5 μg/kg/min
• Stage IV/V chronic renal failure, not on dialysis
• Severe hepatocellular insufficiency at inclusion (Child-Pugh C)
• Bradycardia < 50 bpm on antiarrhythmic drugs
• Clinical convulsive seizure at inclusion
• Predictable inability to answer the questionnaire (cognitive impairment, non-Francophone)
• Known participation in another interventional research study (RIPH1 or RIPH2)
• Known situation of deprivation of liberty or legal protection (safeguard of justice, guardianship or curatorship)

Критерии исключения

Patients under court protection will be excluded as soon as the investigator is aware of their status.

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

Лечение

Центры проведения

Франция · 15 центров

• CHU d'Angers - RCA (Réanimation Chirurgicale A) — Angers
• CHU d'Angers - RCB (Réanimation Chirurgicale B) — Angers
• CHU de Brest - Réanimation Cardiaque — Brest
• CH Louis Pasteur (Chartres) - Réanimation — Chartres
• CHU de Nantes - Hôpital Guillaume et René Laennec - Réanimation Chirurgicale Polyvalente — Nantes
• CHU de Nantes - Hôpital Guillaume et René Laennec - Réanimation CTCV — Nantes
• CHU de Nantes - Hôtel-Dieu - Réanimation chirurgicale — Nantes
• CHU de Poitiers - Réanimation Chirurgicale — Poitiers
• … и ещё 7 центров

Идентификаторы

NCT: NCT07043023 · 35RC22_8943_LIDOCRIT · 2024-517749-15-00 · 25.00870.000409

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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