MORPHINE SULFATE for Postoperative pain following major laparoscopic abdominal surgery

Inclusion criteria

• {"criterion_text":"- Age ≥18 years\n- Scheduled laparoscopic abdominal surgery with an expected operative duration of 2 hours or more\n- Affiliation to the national health insurance system\n- Signed informed consent to participate in the study"}

Exclusion criteria

• {"criterion_text":"- Allergy or intolerance to any of the following medications: paracetamol, nefopam, ketoprofen, tramadol, morphine, sufentanil, lidocaine, propofol, ketamine, dexamethasone, or droperidol\n- Patient unable to self-assess pain using a numerical rating scale (0–10) (e.g., due to language barrier)\n- Pregnant or breastfeeding women\n- Patient under legal guardianship, legal protection, or deprived of liberty\n- Contraindication to any of these medications (refer to the Summary of Product Characteristics): paracetamol, ketoprofen, nefopam, tramadol, morphine, sufentanil, lidocaine, propofol, ketamine, dexamethasone, or droperidol\n- Chronic use of monoamine oxidase inhibitors or CYP2D6 inhibitors\n- Chronic preoperative use of level 2 or 3 analgesics\n- Outpatient surgery\n- Surgery requiring postoperative admission to an intensive care unit (ICU)\n- Patient on long-term oxygen therapy\n- Patient with psychiatric disorders\n- Patient with neurodegenerative diseases"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the multidimensional score validated in French assessing postoperative patient recovery: the QoR-15 (Quality of Recovery-15) score at 24 hours after surgery.","definition_or_measurement_approach":"QoR-15 (Quality of Recovery-15) score measured at 24 hours postoperatively (French-validated questionnaire)."}

Secondary endpoints

• {"endpoint_text":"- QoR-15 questionnaire scores at 48 and 72 hours","definition_or_measurement_approach":"QoR-15 score measured at 48 and 72 hours postoperatively."}
• {"endpoint_text":"- Mean postoperative pain NRS (0–10) scores in the Post-Anesthesia Care Unit (PACU), and at 24, 48, and 72 hours","definition_or_measurement_approach":"Pain intensity assessed on an 11-point Numerical Rating Scale (NRS 0–10) in PACU and at 24, 48, 72 hours."}
• {"endpoint_text":"- Opioid consumption expressed in oral morphine equivalent at 24 and 72 hours postoperatively","definition_or_measurement_approach":"Total opioid consumption converted to oral morphine equivalents at 24 and 72 hours postoperatively."}
• {"endpoint_text":"- Analgesic efficacy after opioid administration, assessed by NRS (0–10) two hours post opioid administration","definition_or_measurement_approach":"NRS (0–10) assessed 2 hours after opioid administration to evaluate analgesic efficacy."}
• {"endpoint_text":"- Length of stay in the PACU (minutes) and total postoperative hospital stay (days)","definition_or_measurement_approach":"Duration in PACU measured in minutes; total postoperative hospital length of stay measured in days."}
• {"endpoint_text":"- Occurrence of the following adverse effects after opioid use: nausea/vomiting, ileus, hypoxemia, pruritus, confusion (assessed by CAM tool)","definition_or_measurement_approach":"Incidence of listed opioid-related adverse events within 72 hours postoperatively; confusion assessed using the CAM tool."}
• {"endpoint_text":"- Pain management satisfaction score, evaluated on a numerical scale from 0 to 10 (0 = total dissatisfaction, 10 = total satisfaction) at hospital discharge","definition_or_measurement_approach":"Patient-reported satisfaction score (0–10) at hospital discharge."}
• {"endpoint_text":"- Number of patients consuming opioids daily at 1 and 3 months post-discharge","definition_or_measurement_approach":"Count of patients reporting daily opioid consumption at 1 and 3 months after discharge."}
• {"endpoint_text":"- Misuse risk assessment using the POMI-5F scale","definition_or_measurement_approach":"Risk of misuse evaluated with the POMI-5F questionnaire."}
• {"endpoint_text":"- Presence of chronic post-surgical pain at 3 months after surgery","definition_or_measurement_approach":"Assessment of presence of chronic post-surgical pain at 3 months post-surgery."}

France

Earliest CTIS Part Ii Submission Date

18-11-2025

Latest Decision Or Authorization Date

22-12-2025

Processing Time Days

34

Number Of Sites

1

Number Of Participants

140

Primary sponsor

Full Name

Centre Hospitalier Universitaire Amiens Picardie

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France