Post-surgery Critical IncarePhase 4LIDOCRITNCT07043023
LIDOCRIT : Effect of Continuous Intravenous LIDOcaine on Discomfort in Postoperative CRITical Care Inpatients
A Phase 4 study testing Lidocaine (drug) in people with Post-surgery Critical Incare, run by Rennes University Hospital at 15 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-surgery Critical Incare
- What is being tested?
- Lidocaine (drug)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 15 sitesFrance
- Study dates
- 1 Oct 2025to 1 Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 22Show fewer
- 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)
Who cannot join
- Patients under court protection will be excluded as soon as the investigator is aware of their status.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
France15 sites
CHU d'Angers - RCA (Réanimation Chirurgicale A)
Angers, 49933
Sigismond LASOCKI, MD, 02 41 35 36 35, silasocki@chu-angers.fr
Sigismond LASOCKI, MD
CHU d'Angers - RCB (Réanimation Chirurgicale B)
Angers, 49933
Emmanuel RINEAU, MD, +33 2 41 35 39 51, Emmanuel.Rineau@chu-angers.fr
Emmanuel RINEAU, MD
CHU de Brest - Réanimation Cardiaque
Brest, 29200
Julie LE ROY, MD, +33 2 98 34 73 31, julie.leroy@chu-brest.fr
Julie LE ROY, MD
CH Louis Pasteur (Chartres) - Réanimation
Chartres, 28630
Juliette AUDIBERT, MD, +33 2 37 30 30 30, jaudibert@ch-chartres.fr
Juliette AUDIBERT, MD
CHU de Nantes - Hôpital Guillaume et René Laennec - Réanimation Chirurgicale Polyvalente
Nantes, 44093
Alice ROUILLARD, MD, +33 6 62 26 19 92, Alice.rouillard@chu-nantes.fr
Alice ROUILLARD, MD
CHU de Nantes - Hôpital Guillaume et René Laennec - Réanimation CTCV
Nantes, 44093
Côme GAILLARD, MD, +33 2 44 76 86 71, Come.gaillard@chu-nantes.fr
Côme GAILLARD, MD
CHU de Nantes - Hôtel-Dieu - Réanimation chirurgicale
Nantes, 44093
Alexandre BOURDIOL, MD, +33 2 40 08 73 80, alexandre.bourdiol@chu-nantes.fr
Alexandre BOURDIOL, MD
CHU de Poitiers - Réanimation Chirurgicale
Poitiers, 86021
Quentin SAINT-GENIS, MD, +33 5 49 44 69 96, quentin.saint-genis@chu-poitiers.fr
Quentin SAINT-GENIS, MD
CHU de Rennes - Réanimation chirurgicale
Rennes, 35033
Elodie MASSERET, MD, +33 2 99 28 42 46, elodie.masseret@chu-rennes.fr
Elodie MASSERET, MD
CHU de Rennes - Réanimation CTCV
Rennes, 35033
Grégoire LE GAC, MD, +33 2 99 28 85 94, Gregoire.LE.GAC@chu-rennes.fr
Grégoire LE GAC, MD
CH de Saint-Nazaire - Réanimation médico-chirurgicale - Unité de Surveillance Continue (USC)
Saint-Nazaire, 44600
Michel LEMARIE, MD, +33 2 72 27 80 00, m.lemarie@ch-saintnazaire.fr
Michel LEMARIE, MD
CHRU de Tours - Hôpital Trousseau - Réanimation Chirurgicale
Tours, 37170
Mathilde BARBAZ, MD, +33 2 47 47 78 67, M.BARBAZ@chu-tours.fr
Mathilde BARBAZ, MD
CHRU de Tours - Hôpital Trousseau - Réanimation URTC
Tours, 37170
Mathilde BARBAZ, MD, +33 2 47 47 78 67, M.BARBAZ@chu-tours.fr
Mathilde BARBAZ, MD
CHRU de Tours - Hôpital Trousseau - Unité de Soins Continus
Tours, 37170
Mathilde BARBAZ, MD, +33 2 47 47 78 67, M.BARBAZ@chu-tours.fr
Mathilde BARBAZ, MD
CH Bretagne Atlantique (Vannes) - Réanimation - Unité de Surveillance Continue
Vannes
François MATEOS, MD, +33 2 97 01 41 68, francois.mateos@ch-bretagne-atlantique.fr
François MATEOS, MD
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Post-surgery Critical Incare
- Being tested
- Lidocaine (drug), Placebo
- Keywords
- critical incare, post-surgery, lidocaine, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine (drug)Drug
Also called Lidocaine 2%
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
PlaceboDrug
Also called Sodium chloride 0.9%
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 group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Lidocaine 2%, bolus of 0.075 ml/kg real weight (i.e. 1.5 mg/kg) then continuous intravenous administration by electric syringe at 0.05 ml/kg/h (i.e. 1 mg/kg/h) for 48 hours Receives: Drug: Lidocaine (drug) |
| Placebo | Placebo comparator | Placebo (sodium chloride 0.9%), bolus of 0.075 ml/kg of real weight then continuous intravenous administration by electric syringe at 0.05 ml/kg/h for 48h Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 24 hours of discharge from critical care or, failing that, within 24 hours of the 15th day of hospitalisation in critical care.
Secondary outcomes (12)
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: For the duration of the treatment and 24 hours after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-surgery Critical IncareStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomised, multicentre, double-blind, placebo-controlled clinical trial. Comparison of Lidocaine IVSE to placebo. Randomisation by block in 1:1, stratified according to centre. All patients were randomised as soon as possible and within 6 hours of leaving the operating theatre, into one of two groups: * Experimental group: 2% Lidocaine, bolus of 0.075 ml/kg of 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. * Control group: placebo (sodium chloride 0.9%), bolus of 0.075 ml/kg real weight then IVSE at 0.05 ml/kg/h for 48 hours Treatment is started as soon as possible, up to 2 hours after randomisation. The syringes were prepared by a 'friendly' service (not involved in patient follow-up) and were of identical size to maintain blindness. The randomisation arm was not known to the doctor in charge of the patient.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elodie MASSERET, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043023
- Sponsor's protocol ID
- 35RC22_8943_LIDOCRIT
- Other IDs
- 2024-517749-15-00, 25.00870.000409
- Acronym
- LIDOCRIT
- Status last verified
- Jul 2025
- First submitted
- 13 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIDOCRIT : Effect of Continuous Intravenous LIDOcaine on Discomfort in Postoperative CRITical Care Inpatients
- ClinicalTrials.gov ID
- NCT07043023
- Acronym / sponsor ID
- LIDOCRIT / 35RC22_8943_LIDOCRIT
- Conditions
- Post-surgery Critical Incare
- Keywords
- critical incare, post-surgery, lidocaine, placebo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomised, multicentre, double-blind, placebo-controlled clinical trial. Comparison of Lidocaine IVSE to placebo. Randomisation by block in 1:1, stratified according to centre. All patients were randomised as soon as possible and within 6 hours of leaving the operating theatre, into one of two groups: * Experimental group: 2% Lidocaine, bolus of 0.075 ml/kg of 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. * Control group: placebo (sodium chloride 0.9%), bolus of 0.075 ml/kg real weight then IVSE at 0.05 ml/kg/h for 48 hours Treatment is started as soon as possible, up to 2 hours after randomisation. The syringes were prepared by a 'friendly' service (not involved in patient follow-up) and were of identical size to maintain blindness. The randomisation arm was not known to the doctor in charge of the patient.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: Lidocaine (drug)Lidocaine 2%, bolus of 0.075 ml/kg real weight (i.e. 1.5 mg/kg) then continuous intravenous administration by electric syringe at 0.05 ml/kg/h (i.e. 1 mg/kg/h) for 48 hours |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (sodium chloride 0.9%), bolus of 0.075 ml/kg of real weight then continuous intravenous administration by electric syringe at 0.05 ml/kg/h for 48h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (1 listed)
- Patients under court protection will be excluded as soon as the investigator is aware of their status.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine (drug)Also: Lidocaine 2%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 | Lidocaine |
| PlaceboAlso: Sodium chloride 0.9%Placebo (sodium chloride 0.9%), bolus of 0.075 ml/kg of real weight then IVSE at 0.05 ml/kg/h for 48h | Drug | Placebo |
Primary outcome
IPREA
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.
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).
12 secondary outcomes
IPREA - Sensitivity analysis of the main criterion
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
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
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
Time frame: Over the first 6 post-surgery days
Duration of invasive mechanical ventilation
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
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
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
Time frame: Until day 30
Duration of stay in hospital
Time frame: Until day 30
Occurrence of pneumonia
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
Time frame: Day 30
Incidence of serious adverse reactions attributable to lidocaine
Time frame: For the duration of the treatment and 24 hours after the end of the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elodie MASSERET, MD principal investigator
Rennes University Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine (drug) in people with Post-surgery Critical Incare, run by Rennes University Hospital at 15 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elodie MASSERET, MD (+33 2 99 28 42 46, elodie.masseret@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IPREA (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.