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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• IPREA — Within 24 hours of discharge from critical care or, failing that, within 24 hours of the 15th day of hospitalisation in critical care.
  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).

Trial sites (15)

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