RecruitingPhase 4NCT07423650

Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy

Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy: A Randomized Controlled Double-Blind Trial


Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Enrollment

93 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

  • Patients scheduled for elective pancreatoduodenectomy surgery
  • Agreed to participate in the study

Exclusion Criteria8

  • Refusal to participate
  • Emergency surgery
  • Patients with neurological disorders or other muscular or psychiatric disorders that impede communication
  • Known allergic reactions to the used medication
  • Known hyperalgesia
  • Chronic opioid consumption
  • Patients that require reintervention in the first 48h postoperatively
  • Patients with pancreaticogastrostomy

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Interventions

DRUGNefopam 120mg/day infusion

Nefopam administration will start in the intraoperative period and continue for 48 hours in the postoperative period

DRUGLidocaine Infusion

Lidocaine infusion will begin in the intraoperative period and continue in the postoperative period for 48 hours

DRUGPeridural

This group will receive the stardad practice in our hospital, peridural analgesia alongside a multimodal analgesic approach involving paracetamol 4g/day

DRUGMultimodal IV analgesia

Standard postoperative multimodal pain management regimen


Locations(1)

Prof. O. Fodor Regional Institute of Gastroenterology and Hepatology

Cluj-Napoca, Cluj, Romania

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NCT07423650


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