Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
ID07423650

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

Led by Iuliu Hatieganu University of Medicine and Pharmacy · Updated on 2026-03-24

93

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether continuous administration of nefopam, as part of a multimodal pain management strategy, can reduce opioid use and improve patient satisfaction after pancreatoduodenectomy surgery. The study compares nefopam with two other pain control methods: continuous lidocaine infusion and epidural analgesia. The main questions focus on whether nefopam lowers opioid consumption and postoperative pain levels following this surgery. Participants will be randomly assigned to one of three groups: one receiving standard multimodal analgesics plus epidural analgesia, another receiving standard multimodal analgesics plus continuous nefopam infusion starting during surgery and continuing for 48 hours after, and a third receiving standard multimodal analgesics plus continuous lidocaine infusion during the same periods. All groups receive standard postoperative care including paracetamol. During the study, participants will complete the Quality of Recovery (QoR-15) questionnaire and report pain levels at set times before and after surgery. Researchers will measure opioid use and pain levels from enrollment through 48 hours post-surgery, monitor adverse events, and assess recovery quality. The total participation period focuses on the first 48 hours after surgery for these assessments.

CONDITIONS

Brief Title

Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for elective pancreatoduodenectomy surgery
  • Agreed to participate in the study
  • Age between 18 and 80 years
  • All genders
Not Eligible

You will not qualify if you...

  • Refusal to participate
  • Emergency surgery
  • Neurological, muscular, or psychiatric disorders that impede communication
  • Known allergic reactions to the medications used
  • Known hyperalgesia
  • Chronic opioid consumption
  • Need for reintervention within 48 hours postoperatively
  • Patients with pancreaticogastrostomy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Approximately 2 days

Participants undergo pancreatoduodenectomy surgery and receive continuous infusion of the assigned analgesic (nefopam, lidocaine, or epidural) starting during surgery and continuing for 48 hours after surgery.

1 surgical and immediate post-operative period

Trial Site Locations

Total: 1 location

1

Prof. O. Fodor Regional Institute of Gastroenterology and Hepatology

Cluj-Napoca, Cluj, Romania

Actively Recruiting

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Research Team

A

Andrei O Mitre

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Frequently Asked Questions

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Published Research Related To This Trial

Opioid-sparing effect of nefopam in combination with paracetamol after major abdominal surgery: a randomized double-blind study.

Philippe Cuvillon, Lana Zoric, Christophe Demattei...

https://pubmed.ncbi.nlm.nih.gov/28192892