Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 to 80

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

PhasePhase 4
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment93 (estimated)
SponsorIuliu Hatieganu University of Medicine and Pharmacy
Academic / other
Locations1 site (Cluj-Napoca, Cluj)
StatusRecruiting
StartedMarch 2026
Main results expectedOctober 2026
Study endsOctober 2026
Registry record updatedMarch 24, 2026
Trial IDNCT07423650 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.