LIDOCAINE HYDROCHLORIDE MONOHYDRATE for Major gastrointestinal or abdominal surgery | Postoperative pain (acute)

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- Major digestive or abdominal surgery (pancreatic, hepatic, colorectal, gynaecological, oesophageal, gastric, duodenal, small intestine, etc.)\n- Scheduled intervention\n- Laparotomy\n- Patient in agreement with rachi morphine anaesthesia\n- Membership of a social security scheme\n- Signed informed consent"}

Exclusion criteria

• {"criterion_text":"- Emergency surgery\n- Rhythm disorder at risk of sudden death (e.g. Brugada syndrome)\n- Flecaine as usual treatment\n- Chronic pain with level II or III analgesics\n- Contraindication to non-steroidal anti-inflammatory drugs: history of peptic ulcer disease, stage 3 A renal failure or more (DFG according to CKD EPI < 60 ml/min).\n- Previous bradycardia and/or known conduction disorder (atrioventricular block) / Pacemaker\n- Unstable coronary\n- Myocardial infarction <6 months\n- Severe cardiocirculatory insufficiency\n- Severe liver failure\n- Morphine allergy\n- Allergy to lidocaine\n- Gabapentinoids: pregabalin (Lyrica), gabapentin\n- Patient taking part in another clinical trial, or in a period of exclusion from another clinical trial\n- Inability to understand information relating to the study (for linguistic, psychological or cognitive reasons, or due to a lack of literacy skills)\n- Women who are or may become pregnant (of childbearing age, without effective contraception) or who are breast-feeding\n- Patient deprived of liberty or under guardianship or unable to give consent"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Measured as total IV morphine consumption (mg) from post-interventional monitoring room to 48 hours using Patient Controlled Analgesia (PCA); any oral doses converted to IV morphine equivalent where appropriate."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Maximum verbal numerical scale (0-10) at rest and on exertion recorded every 4 hours after intervention up to 96 hours."}
• {"endpoint_text":"- Time between the end of the operation and the first gas described by the patient (in hours)","definition_or_measurement_approach":"Time (hours) from end of operation to first passage of flatus as reported by patient."}
• {"endpoint_text":"- Total consumption of IV morphine at H12, H24, H72 and H96 in the 2 groups","definition_or_measurement_approach":"Total IV morphine consumption measured at 12, 24, 72 and 96 hours post-intervention and compared between groups."}
• {"endpoint_text":"- Time of first rise in the 2 groups","definition_or_measurement_approach":"Time to first ambulation/first rise as recorded for each group."}
• {"endpoint_text":"- Duration of surgery (in minutes), defined as the time from incision to closure","definition_or_measurement_approach":"Surgical duration measured in minutes from incision to closure."}
• {"endpoint_text":"- Length of hospital stay (in days)","definition_or_measurement_approach":"Number of days hospitalized from surgery until discharge."}
• {"endpoint_text":"- Morphine-related adverse events by investigator (H0, H12, H24, H48, H72 and H96)","definition_or_measurement_approach":"Investigator-assessed morphine-related adverse events collected at H0, H12, H24, H48, H72 and H96."}
• {"endpoint_text":"- Lidocaine-related adverse events by investigator (H0 and H12)","definition_or_measurement_approach":"Investigator-assessed lidocaine-related adverse events collected at H0 and H12."}
• {"endpoint_text":"- Collection of adverse events in the 2 groups","definition_or_measurement_approach":"Collection/recording of all adverse events in both groups throughout trial duration."}

France

Earliest CTIS Part Ii Submission Date

13-05-2025

Latest Decision Or Authorization Date

27-06-2025

Processing Time Days

45

Number Of Sites

1

Number Of Participants

76

Primary sponsor

Full Name

GCS Ramsay Sante Enseignement Et Recherche

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

France