Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy

Phase 4RecruitingNCT07423650

Iuliu Hatieganu University of Medicine and Pharmacy93 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pancreatoduodenectomy Pain Management Opioid Analgesia Multimodal Analgesia

Interventions

Nefopam 120mg/day infusionDRUG

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

Lidocaine InfusionDRUG

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

PeriduralDRUG

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

Multimodal IV analgesiaDRUG

Standard postoperative multimodal pain management regimen

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

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

Continous Infusion of Nefopam for Patients Undergoing Pancreatoduodenectomy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts