Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07423650

Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pancreatoduodenectomy Agnosia Multimodal Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Opioid Analgesia Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Prof. O. Fodor Regional Institute of Gastroenterology and Hepatology

Cluj-Napoca, Cluj, Romania

Location status: Recruiting

Location contact

Andrei O Mitre

CONTACT

[email protected]

+40724275556

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nefopam 120mg/day infusion

Drug

Nefopam administration will start in the intraoperative period and continue for 48 hours in the postoperative period

Lidocaine infusion

Drug

Lidocaine infusion will begin in the intraoperative period and continue in the postoperative period for 48 hours

Peridural

Drug

This group will receive the stardad practice in our hospital, peridural analgesia alongside a multimodal analgesic approach involving paracetamol 4g/day

Multimodal IV analgesia

Drug

Standard postoperative multimodal pain management regimen

Other names: Ketoprofene, Paracetamol, Morphine

Primary outcomes

  1. Opioid consumption

    Time frame: From enrollment to 48 hours after the surgery

    Perioperative opioid consumption, expressed in morphine milligram equivalents, during the intraoperative period and within the first 6, 18, 24, and 48 hours postoperatively.

  2. Pain levels after surgery

    Time frame: From enrollment to 48 hours after the 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.

Secondary outcomes

  1. Quality of Recovery (QoR-15)

    Time frame: From enrollment to 48 hours after the surgery

    Quality of Recovery (QoR-15) scores, assessed preoperatively and at 24 and 48 hours after surgery.

  2. Adverse events

    Time frame: From enrollment to 48 hours postoperative

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrei O Mitre

CONTACT

[email protected]

+40724275556

Sponsors and collaborators

Lead sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.