Continuous nefopam infusion after pancreatoduodenectomy
Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy: A Randomized Controlled Double-Blind Trial
PHASE4 · Iuliu Hatieganu University of Medicine and Pharmacy · NCT07423650
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 | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 93 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Iuliu Hatieganu University of Medicine and Pharmacy (other) |
| Locations | 1 site (Cluj-Napoca, Cluj) |
| Trial ID | NCT07423650 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cluj-Napoca, Cluj
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatoduodenectomy, Pain Management, Opioid Analgesia, Multimodal Analgesia, Nefopam, Opioids, Multimodal analgesia