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RECRUITING
NCT07423650
PHASE4

Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy

Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

93

Start Date

2026-03

Completion Date

2026-10

Last Updated

2026-03-24

Healthy Volunteers

No

Interventions

DRUG

Nefopam 120mg/day infusion

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

DRUG

Lidocaine Infusion

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

DRUG

Peridural

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

DRUG

Multimodal IV analgesia

Standard postoperative multimodal pain management regimen

Locations (1)

Prof. O. Fodor Regional Institute of Gastroenterology and Hepatology

Cluj-Napoca, Cluj, Romania