Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy

Iuliu Hatieganu University of Medicine and Pharmacy

Status and phase: Enrolling; Phase 4

Conditions: Multimodal Analgesia; Pain Management; Opioid Analgesia; Pancreatoduodenectomy

Treatments: Drug: Peridural; Drug: Lidocaine Infusion; Drug: Multimodal IV analgesia; Drug: Nefopam 120mg/day infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT07423650

11348/25.09.2025

Details and patient eligibility

About

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.

Enrollment: 93 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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93 participants in 3 patient groups

Peridural

Active Comparator group

Description:

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

Treatment:

Drug: Multimodal IV analgesia

Drug: Peridural

Nefopam

Experimental group

Description:

Patients will receive standard multimodal analgesic medications plus continuous nefopam infusion from the intraoperative through the postoperative period.

Treatment:

Drug: Multimodal IV analgesia

Drug: Nefopam 120mg/day infusion

Lidocaine

Active Comparator group

Description:

Patients will receive standard multimodal analgesic medications plus continuous lidocaine infusion from the intraoperative through the postoperative period.

Treatment:

Drug: Multimodal IV analgesia

Drug: Lidocaine Infusion