Multimodal Analgesia, Opioid Analgesia, Pain Management, Pancreatoduodenectomy
Conditions
Keywords
Nefopam, Pancreatoduodenectomy, Opioids, Multimodal analgesia
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.
Interventions
DRUGNefopam 120mg/day infusion
Nefopam administration will start in the intraoperative period and continue for 48 hours in the postoperative period
DRUGLidocaine Infusion
Lidocaine infusion will begin in the intraoperative period and continue in the postoperative period for 48 hours
DRUGPeridural
This group will receive the stardad practice in our hospital, peridural analgesia alongside a multimodal analgesic approach involving paracetamol 4g/day
Standard postoperative multimodal pain management regimen
Sponsors
Iuliu Hatieganu University of Medicine and Pharmacy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | 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. |
| Pain levels after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery (QoR-15) | From enrollment to 48 hours after the surgery | Quality of Recovery (QoR-15) scores, assessed preoperatively and at 24 and 48 hours after surgery. |
| Adverse events | 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. |
Countries
Romania
Contacts
CONTACTAndrei O Mitre
Outcome results
None listed