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LIDOCRIT : Effect of Continuous Intravenous LIDOcaine on Discomfort in Postoperative CRITical Care Inpatients
Sponsor: Rennes University Hospital
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
246
Start Date
2025-10-01
Completion Date
2028-06-01
Last Updated
2025-07-04
Healthy Volunteers
No
Conditions
Interventions
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
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
Locations (15)
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
CH de Saint-Nazaire - Réanimation médico-chirurgicale - Unité de Surveillance Continue (USC)
Saint-Nazaire, France
CHRU de Tours - Hôpital Trousseau - Réanimation Chirurgicale
Tours, France
CHRU de Tours - Hôpital Trousseau - Réanimation URTC
Tours, France
CHRU de Tours - Hôpital Trousseau - Unité de Soins Continus
Tours, France
CH Bretagne Atlantique (Vannes) - Réanimation - Unité de Surveillance Continue
Vannes, France