"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."

NCT07869173 | Not Yet Recruiting Phase 3

• 1 other identifier: RC25_0291
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (2)

• effectiveness of the intervention

  3 months

• effectiveness of the intervention

  6 months

Study Arms (2)

Experimental : lidocaïne

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Lidocain DRUG

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)

Experimental : lidocaïne

Placebo DRUG

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)

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 \[65\]
• Porphyria
• Contrai indications to lidocaine:

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (6)

CHU Angers

Angers, 49933, France

Location

CHU Brest

Brest, France

Location

CHD Vendée

La Roche-sur-Yon, France

Location

Chu Nantes

Nantes, 44093, France

Location

CHU Rennes

Rennes, 35000, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Raphaël CINOTTI PhD

CONTACT

0240084731; raphael.cinotti@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): January 15, 2027
• Primary Completion (Estimated): July 15, 2029
• Study Completion (Estimated): July 15, 2029
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)