Menu
Recruiting NCT07423650

Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy

Phase IV Interventional Pancreatoduodenectomy Pain Management Opioid Analgesia Multimodal Analgesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nefopam 120mg/day infusion, Lidocaine Infusion, Peridural, Multimodal IV analgesia.
Who it may be relevant to
Registry conditions: Pancreatoduodenectomy, Pain Management, Opioid Analgesia, Multimodal Analgesia. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Romania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy: A Randomized Controlled Double-Blind Trial

Overview

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.

Interventions

  • Drug Nefopam 120mg/day infusion
    Nefopam administration will start in the intraoperative period and continue for 48 hours in the postoperative period
  • Drug Lidocaine Infusion
    Lidocaine infusion will begin in the intraoperative period and continue in the postoperative period for 48 hours
  • Drug Peridural
    This group will receive the stardad practice in our hospital, peridural analgesia alongside a multimodal analgesic approach involving paracetamol 4g/day
  • Drug Multimodal IV analgesia
    Standard postoperative multimodal pain management regimen

Primary outcome measures

  • Opioid consumption [Time frame: From enrollment to 48 hours after the surgery]
  • Pain levels after surgery [Time frame: From enrollment to 48 hours after the surgery]
Secondary outcome measures (2)
  • Quality of Recovery (QoR-15) [Time frame: From enrollment to 48 hours after the surgery]
  • Adverse events [Time frame: From enrollment to 48 hours postoperative]

Eligibility criteria

Inclusion criteria

  • Patients scheduled for elective pancreatoduodenectomy surgery
  • Agreed to participate in the study

Exclusion criteria

  • Refusal to participate
  • Emergency surgery
  • Patients with neurological disorders or other muscular or psychiatric disorders that impede communication
  • Known allergic reactions to the used medication
  • Known hyperalgesia
  • Chronic opioid consumption
  • Patients that require reintervention in the first 48h postoperatively
  • Patients with pancreaticogastrostomy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Romania · 1 center
  • Prof. O. Fodor Regional Institute of Gastroenterology and Hepatology — Cluj-Napoca

Publications

  • Tramoni G, Viale JP, Cazals C, Bhageerutty K. Morphine-sparing effect of nefopam by continuous intravenous injection after abdominal surgery by laparotomy. Eur J Anaesthesiol. 2003 Dec;20(12):990-2. doi: 10.1017/s0265021503251590. No abstract available. PMID 14690106
  • Cuvillon P, Zoric L, Demattei C, Alonso S, Casano F, L'hermite J, Ripart J, Lefrant JY, Muller L. Opioid-sparing effect of nefopam in combination with paracetamol after major abdominal surgery: a randomized double-blind study. Minerva Anestesiol. 2017 Sep;83(9):914-920. doi: 10.23736/S0375-9393.17.11508-7. Epub 2017 Feb 13. PMID 28192892

Identifiers

NCT: NCT07423650 · 11348/25.09.2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗