Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy: A Randomized Controlled Double-Blind Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Patients scheduled for elective pancreatoduodenectomy surgery
• Agreed to participate in the study
Locations
Other Locations
Romania
Prof. O. Fodor Regional Institute of Gastroenterology and Hepatology
RECRUITING
Cluj-napoca
Contact Information
Primary
Andrei O Mitre
andrei.otto.mitre@elearn.umfcluj.ro
+40724275556
Time Frame
Start Date:2026-03
Estimated Completion Date:2026-10
Participants
Target number of participants:93
Treatments
Active_comparator: Peridural
Patients will receive standard multimodal analgesic medications plus epidural analgesia during the postoperative period.
Experimental: Nefopam
Patients will receive standard multimodal analgesic medications plus continuous nefopam infusion from the intraoperative through the postoperative period.
Active_comparator: Lidocaine
Patients will receive standard multimodal analgesic medications plus continuous lidocaine infusion from the intraoperative through the postoperative period.