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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
246
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
Placebo (sodium chloride 0.9%), bolus of 0.075 ml/kg of real weight then IVSE at 0.05 ml/kg/h for 48h
CHU d'Angers - RCA (Réanimation Chirurgicale A)
Angers, France
CHU d'Angers - RCB (Réanimation Chirurgicale B)
Angers, France
CHU de Brest - Réanimation Cardiaque
Brest, France
CH Louis Pasteur (Chartres) - Réanimation
Chartres, France
CHU de Nantes - Hôpital Guillaume et René Laennec - Réanimation Chirurgicale Polyvalente
Nantes, France
CHU de Nantes - Hôpital Guillaume et René Laennec - Réanimation CTCV
Nantes, France
CHU de Nantes - Hôtel-Dieu - Réanimation chirurgicale
Nantes, France
CHU de Poitiers - Réanimation Chirurgicale
Poitiers, France
CHU de Rennes - Réanimation chirurgicale
Rennes, France
CHU de Rennes - Réanimation CTCV
Rennes, France
...and 5 more locations
IPREA
Overall score on the Inconforts of Patients in Intensive Care (IPREA) questionnaire. Comfort is assessed by the patient him/herself, using a self-assessment scale IPREA, which is explained and conducted with the medical or paramedical staff in the intensive care unit or intensive care unit. The IPREA questionnaire was developed specifically for critical incare patients. The patient rates his discomfort on a 100 mm graduated visual scale presented horizontally (0: no discomfort, 100: maximum discomfort) for 18 items including (noise, excess light, discomfort of sleeping in intensive care bed, lack of sleep, thirst, hunger, cold, heat, pain, presence of pipes, lack of privacy, anxiety, isolation, limitation of visits, absence of telephone, lack of information, difficulty breathing, depression). The overall score is calculated from the average of each item, giving a score from 0 (minimum discomfort) to 100 (maximum discomfort).
Time frame: Within 24 hours of discharge from critical care or, failing that, within 24 hours of the 15th day of hospitalisation in critical care.
IPREA - Sensitivity analysis of the main criterion
Sensitivity analysis of the main criterion Data from patients who died will be imputed according to the following strategy: * the values of patients who died before D7 at the worst value of the IPREA score (100), * values for patients who died after D7 by multiple imputation. The IPREA questionnaire was developed specifically for critical incare patients. The patient rates his discomfort on a 100 mm graduated visual scale presented horizontally (0: no discomfort, 100: maximum discomfort) for 18 items including (noise, excess light, discomfort of sleeping in intensive care bed, lack of sleep, thirst, hunger, cold, heat, pain, presence of pipes, lack of privacy, anxiety, isolation, limitation of visits, absence of telephone, lack of information, difficulty breathing, depression). The overall score is calculated from the average of each item, giving a score from 0 (minimum discomfort) to 100 (maximum discomfort).
Time frame: Within 24 hours of discharge from critical care or, failing that, within 24 hours of the 15th day of hospitalisation in critical care.
IPREA
Patients who have died will be considered as not evaluable. Overall score on the IPREA questionnaire. Comfort is assessed by the patient him/herself, using a self-assessment scale IPREA, which is explained and conducted with the medical or paramedical staff in the intensive care unit or intensive care unit. The IPREA questionnaire was developed specifically for critical incare patients. The patient rates his discomfort on a 100 mm graduated visual scale presented horizontally (0: no discomfort, 100: maximum discomfort) for 18 items including (noise, excess light, discomfort of sleeping in intensive care bed, lack of sleep, thirst, hunger, cold, heat, pain, presence of pipes, lack of privacy, anxiety, isolation, limitation of visits, absence of telephone, lack of information, difficulty breathing, depression). The overall score is calculated from the average of each item, giving a score from 0 (minimum discomfort) to 100 (maximum discomfort).
Time frame: 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
Result per item of 8 items of the IPREA score, achieved : * Noise * Thirst * Pain * Medical devices (catheters, intubation tubes, etc.) * Sleepiness * Dyspnoea * Anxiety * Depression Patients who have died will be considered as not evaluable. Overall score on the IPREA (Inconforts of Patients in Intensive Care) questionnaire. Comfort is assessed by the patient him/herself, using a self-assessment scale IPREA, which is explained and conducted with the medical or paramedical staff in the intensive care unit or intensive care unit. The IPREA questionnaire was developed specifically for critical incare patients. The patient rates his discomfort on a 100 mm graduated visual scale presented horizontally (0: no discomfort, 100: maximum discomfort) for 18 items. The overall score is calculated from the average of each item, giving a score from 0 (minimum discomfort) to 100 (maximum discomfort).
Time frame: 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
Cumulative opioid consumption (in mg IV morphine equivalent, or µg Remifentanil or µg Sufentanil) In the event of death or premature exit, the criterion will be assessed for the period preceding death or exit.
Time frame: Over the first 6 post-surgery days
Duration of invasive mechanical ventilation
Duration of invasive mechanical ventilation in critical care In the event of death or premature exit, the criterion will be assessed for the period preceding death or exit.
Time frame: 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
Occurrence of re-intubation In the event of death or premature exit, the criterion will be assessed for the period preceding death or exit.
Time frame: 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
Duration of sedation In the event of death or premature exit, the criterion will be assessed for the period preceding death or exit.
Time frame: 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
Duration of stay in critical care, including, in the event of transfer, the stay in critical care in the transfer hospital In the event of death or premature exit, the criterion will be assessed for the period preceding death or exit.
Time frame: Until day 30
Duration of stay in hospital
Duration of stay in hospital including, in the event of transfer, the stay in the transfer hospital In the event of death or premature exit, the criterion will be assessed for the period preceding death or exit.
Time frame: Until day 30
Occurrence of pneumonia
Occurrence of pneumonia according to the Recommandations Formalisées d'Experts (RFE) Société française d'anesthésie et de réanimation (SFAR)/Société de Réanimation de Langue Française (SRLF) 2017 'Healthcare-associated pneumonia' criteria in the appendix. In the event of death or premature exit, the criterion will be assessed for the period preceding death or exit.
Time frame: 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
Vital status In the event of premature discharge, the vital status will be censored on the date of discharge.
Time frame: Day 30
Incidence of serious adverse reactions attributable to lidocaine
Incidence of serious adverse reactions attributable to lidocaine : * Conduction disorders on Electrocardiogram (ECG) not present before treatment, * Cardiac arrest * Respiratory arrest * Anaphylactic shock of any grade * Hypotension requiring the introduction of noradrenaline or a significant (\>20%) increase in the dose of noradrenaline (if treatment with noradrenaline was already underway when the experimental treatment was initiated). * Bradycardia requiring the introduction of atropine * Bradycardia requiring the introduction of dobutamine * Bradycardia requiring the introduction of isoprenaline * Convulsive seizures * Presumed lidocaine intoxication defined by the presence of two of the following: * Vertigo * Dysgeusia * Perioral and lingual paresthesias, dysarthria * Blurred vision * Tinnitus, hearing dysfunction * Tremor In the event of death or premature exit, the criterion will be assessed for the period preceding death or exit.
Time frame: For the duration of the treatment and 24 hours after the end of the treatment
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