A Phase 4 interventional study of Nefopam 120mg/day infusion and Lidocaine Infusion in Pancreatoduodenectomy, Pain Management and Opioid Analgesia, sponsored by Iuliu Hatieganu University of Medicine and Pharmacy. Recruiting at 1 site in Romania. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Iuliu Hatieganu University of Medicine and Pharmacy · Phase 4, Interventional, and Treatment
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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.
Iuliu Hatieganu University of Medicine and Pharmacy is the lead sponsor of 56 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Patients will receive standard multimodal analgesic medications plus epidural analgesia during the postoperative period.
Drug: Peridural · Drug: Multimodal IV analgesia
Patients will receive standard multimodal analgesic medications plus continuous nefopam infusion from the intraoperative through the postoperative period.
Drug: Nefopam 120mg/day infusion · Drug: Multimodal IV analgesia
Patients will receive standard multimodal analgesic medications plus continuous lidocaine infusion from the intraoperative through the postoperative period.
Drug: Lidocaine Infusion · Drug: Multimodal IV analgesia
Drug page: Nefopam
Nefopam administration will start in the intraoperative period and continue for 48 hours in the postoperative period
Lidocaine infusion will begin in the intraoperative period and continue in the postoperative period for 48 hours
This group will receive the stardad practice in our hospital, peridural analgesia alongside a multimodal analgesic approach involving paracetamol 4g/day
Standard postoperative multimodal pain management regimen
Also known as: Ketoprofene, Paracetamol, Morphine
Opioid consumption
Perioperative opioid consumption, expressed in morphine milligram equivalents, during the intraoperative period and within the first 6, 18, 24, and 48 hours postoperatively.
Time frame: From enrollment to 48 hours after the surgery
Pain levels after surgery
Numeric Rating Scale (NRS) pain scores at rest and during straining (coughing), assessed at 30 minutes, 6 hours, 18 hours, 24 hours, and 48 hours postoperatively.
Time frame: From enrollment to 48 hours after the surgery
Quality of Recovery (QoR-15)
Quality of Recovery (QoR-15) scores, assessed preoperatively and at 24 and 48 hours after surgery.
Time frame: From enrollment to 48 hours after the surgery
Adverse events
Incidence of adverse events: pruritus, tachycardia, bradycardia, arrhythmia, lidocaine toxicity signs (metallic taste in the mouth, oral numbness, tinnitus, blurred vision), nausea, vomiting, rescue antiemetic etc.
Time frame: From enrollment to 48 hours postoperative
Plan to share: Undecided
Start is estimated for Mar 2026; primary completion for Oct 2026, 7 months later.
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Studies of the drug tested here: Nefopam
Agnosia
Iuliu Hatieganu University of Medicine and Pharmacy