Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy

March 19, 2026 updated by: Andrei Mitre, Iuliu Hatieganu University of Medicine and Pharmacy

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

93

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Romania
    • Cluj
      • Cluj-Napoca, Cluj, Romania
        • Recruiting
        • Prof. O. Fodor Regional Institute of Gastroenterology and Hepatology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Peridural
Patients will receive standard multimodal analgesic medications plus epidural analgesia during the postoperative period.
Drug: Multimodal IV analgesia
Standard postoperative multimodal pain management regimen
Other Names:
  • Paracetamol
  • Morphine
  • Ketoprofene
Drug: Peridural
This group will receive the stardad practice in our hospital, peridural analgesia alongside a multimodal analgesic approach involving paracetamol 4g/day
Experimental: Nefopam
Patients will receive standard multimodal analgesic medications plus continuous nefopam infusion from the intraoperative through the postoperative period.
Drug: Multimodal IV analgesia
Standard postoperative multimodal pain management regimen
Other Names:
  • Paracetamol
  • Morphine
  • Ketoprofene
Drug: Nefopam 120mg/day infusion
Nefopam administration will start in the intraoperative period and continue for 48 hours in the postoperative period
Active Comparator: Lidocaine
Patients will receive standard multimodal analgesic medications plus continuous lidocaine infusion from the intraoperative through the postoperative period.
Drug: Multimodal IV analgesia
Standard postoperative multimodal pain management regimen
Other Names:
  • Paracetamol
  • Morphine
  • Ketoprofene
Drug: Lidocaine Infusion
Lidocaine infusion will begin in the intraoperative period and continue in the postoperative period for 48 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to 48 hours after the surgery
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.
From enrollment to 48 hours after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to 48 hours after the surgery
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.
From enrollment to 48 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 14, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11348/25.09.2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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