NCT07423650

Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 93 (estimated)
• Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatoduodenectomy
• Pain Management
• Opioid Analgesia
• Multimodal Analgesia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2026-02-20
• Last updated: 2026-03-24

Locations

1 site across 1 country: Romania