Continuous nefopam infusion after pancreatoduodenectomy
Official title: Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy: A Randomized Controlled Double-Blind Trial
Run by Iuliu Hatieganu University of Medicine and Pharmacy · NCT07423650 · Data updated 2026-11-12
This trial will test whether a continuous infusion of nefopam can lower opioid use and reduce pain for people having a pancreatoduodenectomy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 93 (estimated) |
| Sponsor | Iuliu Hatieganu University of Medicine and Pharmacy Academic / other |
| Locations | 1 site (Cluj-Napoca, Cluj) |
| Status | Recruiting |
| Started | March 2026 |
| Main results expected | October 2026 |
| Study ends | October 2026 |
| Registry record updated | March 24, 2026 |
| Trial ID | NCT07423650 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults scheduled for elective pancreatoduodenectomy who can consent and do not have chronic opioid use, communication-impairing neurological or psychiatric disorders, or allergies to the study medications.
✕Probably not a fit
Patients with chronic opioid consumption, known hyperalgesia or allergies to the study drugs, those requiring emergency surgery, early reintervention within 48 hours, or with pancreaticogastrostomy are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients undergoing elective pancreatoduodenectomy will receive one of three perioperative analgesic strategies—continuous nefopam infusion (120 mg/day), continuous lidocaine infusion, or epidural analgesia—as part of a multimodal pain management protocol. Researchers will track opioid consumption, patient-reported pain scores at predefined time points, and recovery quality using the QoR-15 questionnaire. Outcomes will be compared between groups to see which approach provides better pain control and reduces opioid requirements. The trial is conducted at a single tertiary gastrointestinal surgery center in Cluj-Napoca, Romania.
Why it matters
Potential benefit: If successful, this approach could reduce postoperative opioid use and improve pain control and recovery quality after pancreatoduodenectomy.
How similar studies have gone: Perioperative nefopam and lidocaine infusions and epidural analgesia have shown opioid-sparing and pain-reducing effects in other surgical populations, although direct head-to-head data specifically in pancreatoduodenectomy are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients scheduled for elective pancreatoduodenectomy surgery 2. Agreed to participate in the study Exclusion Criteria: 1. Refusal to participate 2. Emergency surgery 3. Patients with neurological disorders or other muscular or psychiatric disorders that impede communication 4. Known allergic reactions to the used medication 5. Known hyperalgesia 6. Chronic opioid consumption 7. Patients that require reintervention in the first 48h postoperatively 8. Patients with pancreaticogastrostomy
Where it's running
-
Prof. O. Fodor Regional Institute of Gastroenterology and Hepatology
Cluj-Napoca, Cluj, Romania Recruiting
Study contacts
- Study coordinator: Andrei O Mitre
- Email: andrei.otto.mitre@elearn.umfcluj.ro
- Phone: +40724275556
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.