Health TrialsbyHealthPanel

Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy

ConditionsPancreatoduodenectomyPain ManagementOpioid AnalgesiaMultimodal Analgesia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorIuliu Hatieganu University of Medicine and Pharmacy

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients scheduled for elective pancreatoduodenectomy surgery

Agreed to participate in the study

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

93 Participants
are divided into 3 treatment groups
Group A: PeriduralActive comparator 2 interventions
Group B: NefopamExperimental treatment 2 interventions
Group C: LidocaineActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to 48 hours after the surgery
2

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.

Time frame
From enrollment to 48 hours after the surgery

Secondary outcomes

1

Quality of Recovery (QoR-15)

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

Time frame
From enrollment to 48 hours after the surgery
2

Adverse events

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.

Time frame
From enrollment to 48 hours postoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Iuliu Hatieganu University of Medicine and Pharmacy

Lead sponsor

Source ClinicalTrials.gov
Apply now