Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy

NCT07423650 | Recruiting Phase 4 DMC

• 1 other identifier: 11348/25.09.2025
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatoduodenectomy; Pain Management; Opioid Analgesia; Multimodal Analgesia

Keywords

Nefopam; Pancreatoduodenectomy; Opioids; Multimodal analgesia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From enrollment to 48 hours after the surgery

Secondary Outcomes (2)

• Quality of Recovery (QoR-15)

  From enrollment to 48 hours after the surgery

• Adverse events

  From enrollment to 48 hours postoperative

Study Arms (3)

Peridural

ACTIVE COMPARATOR

Patients will receive standard multimodal analgesic medications plus epidural analgesia during the postoperative period.

Drug: Peridural; Drug: Multimodal IV analgesia

Nefopam

EXPERIMENTAL

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

Lidocaine

ACTIVE COMPARATOR

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

Interventions

Nefopam 120mg/day infusion DRUG

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

Nefopam

Lidocaine Infusion DRUG

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

Lidocaine

Peridural DRUG

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

Peridural

Multimodal IV analgesia DRUG

Standard postoperative multimodal pain management regimen

Also known as: Ketoprofene, Paracetamol, Morphine

Lidocaine; Nefopam; Peridural

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (1)

Prof. O. Fodor Regional Institute of Gastroenterology and Hepatology

Cluj-Napoca, Cluj, Romania

RECRUITING

Related Publications (2)

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Agnosia

Interventions

Nefopam; Acetaminophen; Morphine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxazocines; Azocines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Andrei O Mitre

CONTACT

+40724275556; andrei.otto.mitre@elearn.umfcluj.ro

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

RO (1)