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"Evaluation of the Efficacy of Intravenous Lidocaine on Chronic Post-operative Pain in Patients Requiring Emergency Abdominal Surgery. A Multicentre, Randomised, Controlled, Double-blind Study."
Sponsor: Nantes University Hospital
Summary
Chronic pain is a major public health issue. According to the most recent sources, it affects around 11 million people in France, leading to a significant deterioration in patients' quality of life, limitations in their activities of daily living, and an impact on their mental health (anxiety and depression symptoms). Furthermore, chronic pain imposes a significant economic cost on society. In France, it is estimated that 10 million surgical or interventional procedures are carried out each year. However, the most recent epidemiological data suggest that 20 to 30 per cent of patients will experience chronic post-surgical pain (CPSP) within 3 to 6 months following the procedure. It is therefore essential to improve perioperative care in order to reduce patients' CSPS: this would bring major benefits at both the individual and societal levels. Lidocaine is a local anaesthetic that has been widely used in human clinical practice for decades in the management of acute pain. Evidence also suggests that its use as a continuous intravenous infusion may have a beneficial effect on post-operative pain and reduce its incidence, but there are no guidelines regarding the use of lidocaine in this context. It therefore seems necessary to evaluate the efficacy of intravenous lidocaine on post-operative pain. The Investigators propose to evaluate the efficacy of intravenous lidocaine on post-operative pain in a large-scale, multicentre, randomised, placebo-controlled trial (266 patients) involving patients requiring emergency abdominal surgery, a population at high risk of post-operative pain that has been little studied in the literature. In this study, we will assess the impact of post-operative pain on patients' quality of life and mental health.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
266
Start Date
2027-01-15
Completion Date
2029-07-15
Last Updated
2026-10-09
Healthy Volunteers
No
Conditions
Interventions
Lidocain
The investigator then administers a volume corresponding to a bolus of 1.5 mg/kg of lidocaine and then starts an infusion of 1.5 mg/kg/h of lidocaine (based on the patient's theoretical ideal weight)
Placebo
The investigator then administers a volume corresponding to a bolus of 1.5 mg/kg of placebo, and then starts an infusion of 1.5 mg/kg/h of placebo (based on the patient's theoretical ideal weight)
Locations (6)
CHU Angers
Angers, France
CHU Brest
Brest, France
CHD Vendée
La Roche-sur-Yon, France
Chu Nantes
Nantes, France
CHU Rennes
Rennes, France
CHU Toulouse
Toulouse, France