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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.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523682-24-00
Enrollment
266
Registered
2026-08-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

emergency abdominal surgery

Brief summary

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.

Detailed description

- 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)

Interventions

DRUG9 %
DRUGsolution injectable

Sponsors

Centre Hospitalier Universitaire De Nantes
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
- 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 disorder

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 18, 2026