NCT07423650 Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy
| NCT ID | NCT07423650 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Iuliu Hatieganu University of Medicine and Pharmacy |
| Condition | Pancreatoduodenectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 93 participants |
| Start Date | 2026-03 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 93 participants in total. It began in 2026-03 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07423650 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Pancreatoduodenectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07423650 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07423650 currently recruiting?
Yes, NCT07423650 is actively recruiting participants. Contact the research team at andrei.otto.mitre@elearn.umfcluj.ro for enrollment information.
Where is the NCT07423650 trial being conducted?
This trial is being conducted at Cluj-Napoca, Romania.
Who is sponsoring the NCT07423650 clinical trial?
NCT07423650 is sponsored by Iuliu Hatieganu University of Medicine and Pharmacy. The trial plans to enroll 93 participants.