Evaluation of the efficacy of intravenous lidocaine on chronic postoperative pain in patients requiring emergency abdominal surgery. Randomized, double-blind, controlled, multicenter study – LIDOC-POPEYE.

Condition studied

emergency abdominal surgery

Investigational medicinal product(s)

Eligibility

Primary endpoint

The inclusion criterion for the study is the proportion of patients with an average pain intensity of ≥ 4/10 in the abdomen during the 7 days prior to assessment, as measured using a Simple Numerical Scale, 6 months after surgery.

Endpoint detail

- The Brief Pain Inventory (BPI) scale in its simplified version at 3 and 6 months after randomization o Total score for chronic pain assessment o Pain intensity subdomain o Pain interference subdomain, - Use of acetaminophen, nonsteroidal anti-inflammatory drugs, nefopam, tramadol, oral morphine, tricyclic antidepressants, serotonin and norepinephrine reuptake inhibitors (duloxetine, venlafaxine), and gabapentinoids (gabapentin, pregabalin) in the Post- , upon hospital discharge, at 3 months, and at 6 months (prescribed doses)., - Quality of life: PROMIS-29 Health-Related Quality of Life Scale at 3 and 6 months o Subscores by dimension:, - Numerical scale assessing pain intensity, - Mental health regarding anxiety and depression symptoms: Hospital Anxiety and Depression Scale (HADS) at 3 and 6 months o Anxiety & Depression Subscore, - Efficacy will be assessed based on the patient’s psychosocial profile: sleep disorders , history of anxiety-depressive disorders , presence of chronic pain (e.g., long-term morphine use, fibromyalgia), - Tolerance will be assessed by the administration of intravenous lipids in the context of acute intraoperative local anesthetic toxicity (cardiac arrest, unexplained shock, convulsions)