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A phase III, randomized, double-blind study assessing the efficacy and safety of intravenous lidocaine versus placebo in patients receiving intrathecal morphine analgesia in major digestive or abdominal surgery by laparotomy

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521206-18-00
Acronym
LIDORACHI
Enrollment
76
Registered
2025-06-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-27

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

Conditions

Major patients receiving morphine spinal anaesthesia for major gastrointestinal or abdominal surgery by scheduled laparotomy.

Brief summary

Total consumption of morphine received postoperatively from the post-interventional monitoring room to H48 (in mg) in IV by PCA (Patient Controlled Analgesia), and oral dose converted to equivalent IV morphine where appropriate

Detailed description

Maximum score of the verbal numerical scale (scored from 0 to 10) at rest and during exertion (cough/mobilisation) over the last 12, 24, 48, 72 and 96 hours. The verbal numerical scale was collected every 4 hours after the end of the intervention until H96, Time between the end of the operation and the first gas described by the patient (in hours), Total consumption of IV morphine at H12, H24, H72 and H96 in the 2 groups, Time of first rise in the 2 groups, Duration of surgery (in minutes), defined as the time from incision to closure, Length of hospital stay (in days), Morphine-related adverse events by investigator (H0, H12, H24, H48, H72 and H96), Lidocaine-related adverse events by investigator (H0 and H12), Collection of adverse events in the 2 groups

Interventions

DRUGsolution injectable
DRUGSODIUM CHLORIDE

Sponsors

GCS Ramsay Sante Enseignement Et Recherche
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Total consumption of morphine received postoperatively from the post-interventional monitoring room to H48 (in mg) in IV by PCA (Patient Controlled Analgesia), and oral dose converted to equivalent IV morphine where appropriate

Secondary

MeasureTime frame
Maximum score of the verbal numerical scale (scored from 0 to 10) at rest and during exertion (cough/mobilisation) over the last 12, 24, 48, 72 and 96 hours. The verbal numerical scale was collected every 4 hours after the end of the intervention until H96, Time between the end of the operation and the first gas described by the patient (in hours), Total consumption of IV morphine at H12, H24, H72 and H96 in the 2 groups, Time of first rise in the 2 groups, Duration of surgery (in minutes), defined as the time from incision to closure, Length of hospital stay (in days), Morphine-related adverse events by investigator (H0, H12, H24, H48, H72 and H96), Lidocaine-related adverse events by investigator (H0 and H12), Collection of adverse events in the 2 groups

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026