Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy

Phase 4 Recruiting 93 enrolled Iuliu Hatieganu University of Medicine and Pharmacy

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2026-03
Primary completion: 2026-10
Completion: 2026-10

Outcome

Missed primary endpoint

paper As the main endpoint, morphine consumption over the study period was similar between nefopam and the control group (respectively, 53±37 and 54±34 mg, P=0.86). PMID 28192892 ↗

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Lidocaine	Other / unclassified	—	—
Subject	Nefopam	Small molecule	120 mg	Intravenous
Background	Acetaminophen	Small molecule	—	Intravenous
Background	Morphine	Other / unclassified	—	Intravenous
Background	Multimodal IV analgesia	Unknown	—	—

Indications

No indication recorded.