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NCT07914335
Tramadol Versus Morphine for Postoperative Pain Relief Following Laparoscopic Abdominal Surgery
Conditions: Multimodal Analgesia, Tramadol, Enhanced Recovery After Surgery, Opioid and Postoperative Pain
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 140
Sponsor: Centre Hospitalier Universitaire, Amiens
Location: CHU Amiens-Picardie Amiens
Summary
Tramadol is commonly used postoperatively due to its ease of administration, but it carries several risks, including interindividual variability, drug interactions, neuropsychiatric risks in elderly patients, and long-term dependence. Although its analgesic efficacy is comparable to that of strong opioids, its role in a multimodal analgesia strategy remains insufficiently studied. Research tailored to current clinical practices is needed to accurately assess its tolerance profile.
Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years
* Patient undergoing scheduled laparoscopic abdominal surgery lasting an estimated 2 hours or more.
* Patient affiliated to the social security system.
* Patient signature of consent to participate in the study
Exclusion Criteria:
* Allergy or intolerance to any of the following medicines: paracetamol, nefopam, ketoprofen, tramadol, morphine, Sufentanil, lidocaine, propofol, ketamine, dexamethasone and droleptan.
* Contraindications to any of these medicines: paracetamol, ketoprofen, nefopam, tramadol, morphine, Sufentanil, lidocaine, propofol, ketamine, dexamethasone and droleptan (see Summaries of Product Characteristics).
* Chronic use of monoamine oxidase inhibitors or CYP 450 2D6 inhibitors
* Chronic use of level 2 or 3 analgesics preoperatively
* Ambulatory surgery
* Surgery requiring post-operative admission to an intensive care unit.
* Patients on long-term oxygen therapy
* Patients suffering from psychiatric pathologies.
* Patient suffering from neurodegenerative pathologies
* Patient for whom self-assessment of pain using an NRS (0-10) cannot be carried out (language barrier, etc.)
* Pregnant or breast-feeding woman
* Patient under guardianship or deprived of liberty.
Source: ClinicalTrials.gov (NCT07914335). StuddyBuddy aggregates publicly available trial information.