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Recruiting Phase 4 NCT07423650

Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy

Trial Parameters

Condition Pancreatoduodenectomy
Sponsor Iuliu Hatieganu University of Medicine and Pharmacy
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 93
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2026-03
Completion 2026-10
Interventions
Nefopam 120mg/day infusionLidocaine InfusionPeridural

Brief Summary

The goal of this clinical trial is to determine whether continuous nefopam administration, as part of a multimodal analgesia strategy, reduces opioid consumption and improves patient satisfaction after pancreatoduodenectomy. The main questions are: Does nefopam administration reduce opioid consumption after pancreatoduodenectomy? Does nefopam administration reduce postoperative pain levels after pancreatoduodenectomy? Researchers will compare two other analgesic strategies, namely continuous lidocaine infusion and epidural analgesia, to assess whether they lead to better outcomes. Participants will complete the QoR-15 questionnaire and report their pain levels at predefined time points before and after surgery.

Eligibility Criteria

Inclusion Criteria: 1. Patients scheduled for elective pancreatoduodenectomy surgery 2. Agreed to participate in the study Exclusion Criteria: 1. Refusal to participate 2. Emergency surgery 3. Patients with neurological disorders or other muscular or psychiatric disorders that impede communication 4. Known allergic reactions to the used medication 5. Known hyperalgesia 6. Chronic opioid consumption 7. Patients that require reintervention in the first 48h postoperatively 8. Patients with pancreaticogastrostomy

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