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Search / Trial NCT07043023

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

Launched by RENNES UNIVERSITY HOSPITAL · Jun 20, 2025

Trial Information

Current as of July 12, 2025

Not yet recruiting

Keywords

Critical Incare Post Surgery Lidocaine Placebo

ClinConnect Summary

This clinical trial is studying whether giving a medicine called lidocaine through a vein continuously for 48 hours can help reduce discomfort and improve comfort in patients who are recovering in the intensive care unit (ICU) after surgery. Lidocaine is often used to numb pain and has been shown to reduce pain and side effects after major surgeries. This study aims to see if lidocaine can make patients feel more comfortable by reducing pain, difficulty breathing, thirst, and sleep problems during their critical care stay.

To take part, patients need to be adults (over 18) who have just had surgery and are expected to stay in the ICU for at least two days. Examples include people recovering from heart, major abdominal, or serious orthopedic surgeries. Patients must also be covered by social security and able to give consent themselves or have a family member or legal representative agree for them. Some people won’t be able to join, such as those who weigh over 100 kg, are pregnant, have certain medical conditions, or have had specific types of pain relief during surgery. Participants will receive either lidocaine or a placebo (a treatment without the active drug) through a continuous drip and will be asked about their comfort using a simple questionnaire. This trial is not yet recruiting, but it hopes to find better ways to help patients feel more comfortable after surgery while avoiding some side effects of stronger pain medicines.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Patient over 18
  • 2. 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)
  • 3. Anticipated length of stay in critical care ≥ 48h
  • 4. Membership of a social security scheme
  • 5. Informed consent signed by the patient or by a close relative or legal representative or, failing this, the emergency procedure
  • Non-inclusion Criteria:
  • 1. Weight over 100 kg
  • 2. Hypersensitivity to one of the active substances used for anaesthesia or to one of the excipients.
  • 3. Known acute porphyria,
  • 4. Pregnant or breast-feeding women
  • 5. Patients who have received or are about to 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)
  • Exclusion Criteria:
  • Patients under court protection will be excluded as soon as the investigator is aware of their status.

About Rennes University Hospital

Rennes University Hospital, a leading academic medical center in France, is dedicated to advancing healthcare through innovative clinical research and trials. With a strong emphasis on patient-centered care, the hospital integrates cutting-edge scientific research with clinical practice, fostering collaboration among multidisciplinary teams. Its commitment to excellence is reflected in its robust infrastructure and expertise in various medical fields, enabling the development and evaluation of novel therapies and treatment protocols. By participating in clinical trials, Rennes University Hospital aims to enhance patient outcomes and contribute to the global body of medical knowledge.

Locations

Angers, , France

Angers, , France

Brest, , France

Chartres, , France

Nantes, , France

Nantes, , France

Nantes, , France

Poitiers, , France

Rennes, , France

Rennes, , France

Saint Nazaire, , France

Tours, , France

Tours, , France

Tours, , France

Vannes, , France

Patients applied

0 patients applied

Trial Officials

Elodie MASSERET, MD

Principal Investigator

Rennes University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported