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NOT YET RECRUITING
NCT07043023
PHASE4

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

Sponsor: Rennes University Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

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