LIDOCRIT : Effect of continuous intravenous LIDOCaine on discomfort in postoperative CRITical care inpatients

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Rennes

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Decision date (initial)

2025-06-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

DGOS (PHRC interrégional 2022)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Prophylaxis

To determine whether continuous intravenous administration of Lidocaine during the first 48 hours post-operatively improves patients' perceived comfort during their stay in the intensive care unit and continuous monitoring unit (critical care). Within 24 hours before discharge from critical care or, failing that, within 24 hours before the 15th day of hospitalization in critical care.

Secondary objectives 13

1. To determine whether the administration of lidocaine by continuous intravenous infusion (IVSE) during the 48 hours post-operatively reduces certain types of discomfort, including noise, thirst, pain, the presence of medical devices, sleep, dyspnoea, anxiety and depression. Within 24 hours before discharge from critical care or, failing that, within 24 hours before the 15th day of hospitalization in critical care.
2. To determine whether the administration of lidocaine by the continuous intravenous route (IVSE) during the first 48 hours post-operatively reduces patients' post-operative opioid consumption. During the first 6 post-surgery days.
3. To determine whether the administration of lidocaine by the continuous intravenous route (IVSE) within 48 hours post-op reduces the duration of invasive mechanical ventilation (IMV). Until discharge from critical care, including, in the event of transfer, the stay in critical care in the receiving hospital, or, failing that, until day 30.
4. To determine whether the administration of lidocaine by the continuous intravenous route (IVSE) within 48 hours postoperatively reduces the incidence of failed weaning from invasive mechanical ventilation during the critical care stay. 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).
5. To determine whether the administration of lidocaine by the continuous intravenous route (IVSE) during the first 48 hours post-operatively reduces the duration of sedation. 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.
6. To determine whether the administration of lidocaine by the continuous intravenous route (IVSE) during the first 48 hours post-op reduces the length of stay in critical care. Until day 30.
7. To determine whether the administration of lidocaine by the continuous intravenous route (IVSE) during the first 48 hours post-operatively reduces the total length of hospital stay. Until day 30.
8. To determine whether the administration of lidocaine by the continuous intravenous route (IVSE) during the first 48 hours postoperatively reduces mortality on the 30th postoperative day. Day 30.
9. To determine whether the administration of lidocaine by the continuous intravenous route (IVSE) within 48 hours post-op reduces the incidence of healthcare-associated pneumonia. During the stay in critical care, including, in the case of transfer, the stay in critical care in the transfer hospital, up to day 30.
10. To determine whether the administration of lidocaine by the continuous intravenous route (IVSE) within 48 hours post-op reduces the incidence of delirium in critical care. During the stay in critical care, including, in the case of transfer, the stay in critical care in the transfer hospital, up to day 30.
11. To determine whether the administration of lidocaine by the continuous intravenous route (IVSE) in the 48 hours post-operatively has any adverse effects. During the duration of treatment administration and for 24 hours after the end of treatment administration.
12. To determine whether continuous intravenous lidocaine administration within 48 postoperative hours improves patients' perceived comfort during their stay in the intensive care unit (ICU). – Sensitivity analysis. Within 24 hours prior to discharge from ICU or, failing that, within 24 hours prior to the 15th day of ICU hospitalisation.
13. To determine whether continuous intravenous lidocaine administration within 48 postoperative hours improves patients' perceived comfort during their stay in the intensive care unit (ICU). This should be done within 24 hours prior to the 7th day of hospitalisation in critical care.

Conditions and MedDRA coding

Postoperative critical care

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Major patient
2. Patient admitted immediately post-operatively in critical care (scheduled or emergency admission, e.g. post-operative exploratory laparotomy, cardiac surgery, heavy orthopaedic surgery such as polytrauma patients, vascular surgery at risk of complications such as open aortic surgery)
3. Anticipated length of stay in critical care ≥ 48h
4. Membership of a social security scheme
5. Informed consent must be obtained and signed by the patient or by a close relative or legal representative or, failing that, the emergency procedure must be followed

Exclusion criteria 16

1. Weight over 100 kg
2. Hypersensitivity to one of the active substances used for anaesthesia or to one of the excipients
3. Acute porphyria on anamnesis
4. Pregnant or breast-feeding women
5. Patient who has received or will receive peri-medullary analgesia intra-operatively or post-operatively
6. Patient who has received or will receive loco-regional analgesia intra-operatively or post-operatively
7. Severe head injury, open cephalic neurosurgery, interventional neuroradiology
8. Recovered cardiorespiratory arrest
9. Noradrenaline doses > 0.5 μg/kg/min
10. Stage IV/V chronic renal failure, not on dialysis
11. Severe hepatocellular insufficiency at inclusion (Child-Pugh C)
12. Bradycardia < 50 bpm on antiarrhythmic drugs
13. Clinical convulsive seizure at inclusion
14. Predictable inability to answer the questionnaire (cognitive impairment, non-Francophone)
15. Known participation in another interventional research study (RIPH1 or RIPH2)
16. Known situation of deprivation of liberty or legal protection (safeguard of justice, guardianship or curatorship)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall score on the IPREA questionnaire (Inconforts of REAnimation Patients with 18 items). Within 24 hours before discharge from critical care or, failing that, within 24 hours before the 15th day of hospitalization in critical care. Deceased patients will be considered non-evaluable.

Secondary endpoints 13

1. Result per item of 8 items of the IPREA score, Within 24 hours before discharge from critical care or, failing that, within 24 hours before the 15th day of hospitalisation in critical care: - Noise - Thirst - Pain - Medical devices (catheters, intubation tubes, etc.) - Sleepiness - Dyspnoea - Anxiety - Depression. Deceased patients will be considered ineligible for evaluation.
2. Cumulative opiate consumption over the first 6 post-operative days (in equivalent mg of IV morphine, or µg of Remifentanil or µg of Sufentanil). In the event of death or premature discharge, the criterion will be assessed over the period preceding the death or discharge.
3. The duration of invasive mechanical ventilation in critical care. 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. In the event of death or premature discharge, the criterion will be assessed over the period preceding death or discharge.
4. Re-intubation within 48 hours of extubation (until discharge from critical care, including, in the case of transfer, the stay in critical care at the receiving hospital, or, failing that, until day 30). In the event of death or premature discharge, the criterion will be assessed over the period preceding death or discharge.
5. The duration of sedation. 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. In the event of death or premature discharge, the criterion will be assessed over the period preceding death or discharge.
6. The length of stay in critical care, including, in the event of transfer, the stay in critical care in the transfer hospital, over a maximum period of 30 post-operative days. Up to day 30. In the event of death or premature discharge, the criterion will be assessed over the period preceding the death or discharge.
7. The total length of hospital stay including, in the event of transfer, the stay in the transfer hospital, over a maximum period of 30 post-operative days. Up to day 30. In the event of death or premature discharge, the criterion will be assessed over the period preceding the death or discharge.
8. Vital status on the 30th postoperative day. J30. In case of premature discharge, the vital status will be censored as of the discharge date.
9. The incidence of care-associated pneumonia (RFE SFAR/SRLF 2017 ‘Care-associated pneumonia’ criteria in appendix). 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. In the event of death or premature discharge, the criterion will be assessed over the period preceding the death or discharge.
10. The incidence of delirium (measured by CAM ICU). 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. In the event of death or premature discharge, the criterion will be assessed over the period preceding the death or discharge.
11. The incidence of adverse reactions attributable to lidocaine over the duration of treatment administration and 24 hours after the end of treatment administration. In the event of death or premature discharge, the criterion will be assessed over the period preceding the death or discharge.
12. Sensitivity analysis : Overall score on the IPREA questionnaire. Data collected within 24 hours prior to discharge from critical care or, failing that, within 24 hours prior to the 15th day of hospitalisation in critical care. Data for deceased patients will be imputed according to the following strategy: - values ​​for patients who died before day 7 will be assigned to the most unfavorable IPREA score (100), - values ​​for patients who died after day 7 will be assigned by multiple imputation.
13. Overall score on the IPREA questionnaire. Within 24 hours prior to the 7th day of hospitalization in critical care. Deceased patients will be considered ineligible for evaluation.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Rennes

Sponsor organisation

Centre Hospitalier Universitaire De Rennes

Address

2 Rue Henri Le Guilloux

City

Rennes Cedex 9

Postcode

35033

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Rennes

Contact name

Elodie MASSERET

Public contact point

Organisation

Centre Hospitalier Universitaire De Rennes

Contact name

Violaine Benoit

Locations

1 EU/EEA country · 13 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications