A Phase 3 interventional study of Lidocain and Placebo in Chronic Pain, sponsored by Nantes University Hospital. Not yet recruiting at 6 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Nantes University Hospital · Phase 3, Interventional, and Treatment
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.
2,998 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.
This study's planned enrollment of 266 is above the median of 60 across 2,209 interventional studies indexed under Chronic Pain.
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Urological Gastrointestinal Gynaecological
Exclusion Criteria:
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)
Drug: Lidocain
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)
Drug: Placebo
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)
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)
Chronic post-surgical pain
Chronic post-surgical pain is defined as pain with an intensity of ≥ 4 on a Simple Numerical Scale 6 months after surgery.
Time frame: 6 months
effectiveness of the intervention
The effectiveness of the intervention will be assessed using: * The Brief Pain Inventory (BPI) at 3 months after randomisation * Intake of paracetamol, non-steroidal anti-inflammatory drugs, nefopam, tramadol, oral morphine, tricyclic antidepressants, serotonin and noradrenaline reuptake inhibitors (duloxetine, venlafaxine) and gabapentinoids (gabalin, pre-gabalin) in the Post-Interventional Monitoring Unit, on discharge from hospital, and at 3 months (prescribed doses). * Quality of life: PROMIS-29 Health-Related Quality of Life Scale at 3 months
Time frame: 3 months
effectiveness of the intervention
The effectiveness of the intervention will be assessed using: * The Brief Pain Inventory (BPI) at 6 months after randomisation * Intake of paracetamol, non-steroidal anti-inflammatory drugs, nefopam, tramadol, oral morphine, tricyclic antidepressants, serotonin and noradrenaline reuptake inhibitors (duloxetine, venlafaxine) and gabapentinoids (gabalin, pre-gabalin) in the Post-Interventional Monitoring Unit, on discharge from hospital, at 6 months (prescribed doses). * Quality of life: PROMIS-29 Health-Related Quality of Life Scale at 6 months
Time frame: 6 months
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Lidocaine