"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."
Not yet recruitingPhase 3NCT07869173
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- "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."
- Conditions
- Interventions
- Sponsor
- Nantes University Hospital
- Start date
- 2027-01-15
- Primary completion
- 2029-07-15
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 6
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Patients aged over 18 and under 80 * Emergency or semi-emergency abdominal surgery of the following types: Urological Gastrointestinal Gynaecological * Open or laparoscopic surgery * Estimated duration of surgery ≥ 60 minutes Exclusion Criteria: * Use of a regional anaesthesia technique involving epidural analgesia * Surgery as part of a transplant procedure * High-degree atrioventricular block without a pacemaker, chronic treatment with class I antiarrhythmic drugs * Shock defined as a systolic blood pressure ≤ 90 mmHg on admission to the emergency operating theatre * Respiratory failure defined as a respiratory rate \> 25 breaths per minute and/or a transcutaneous oxygen saturation \< 90% on admission to the emergency operating theatre * Neurological impairment defined as a Glasgow Coma Scale score ≤ 13 on admission to the emergency operating theatre * Known dementia * Patients who are active drug users or undergoing withdrawal, given the significant difficulties in managing perioperative analgesia in these patients \[65\] * Pregnancy or breastfeeding. Women of childbearing age will undergo a pregnancy test prior to inclusion. * Porphyria * Contrai indications to lidocaine:
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07869173