Opioid-free anesthesia for duodenopancreatic surgery by laparotomy
Official title: Opioid-free Anesthesia as an Alternative to General Anesthesia in Patients Undergoing Duodenopancreatic Surgery by Laparotomy.
Run by Jagiellonian University · NCT07364864 · Data updated 2026-11-12
This study tests whether opioid-free anesthesia can provide effective pain control for adults undergoing pancreaticoduodenal surgery with laparotomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Jagiellonian University Academic / other |
| Locations | 1 site (Krakow, Lesser Poland Voivodeship) |
| Status | Recruiting |
| Started | September 2, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | September 4, 2026 |
| Trial ID | NCT07364864 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-80 with ASA II-III undergoing pancreaticoduodenal surgery by laparotomy who consent to regional anesthesia and trial participation.
✕Probably not a fit
Patients who require high levels of analgesia not achievable without opioids, or who experience inadequate pain relief with OFA, may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study examines an opioid-free anesthesia approach as an alternative to standard opioid-based anesthesia for patients undergoing duodenopancreatic surgery via laparotomy. By using non-opioid analgesics, co-analgesics, and regional/local anesthesia techniques, the protocol aims to maintain adequate analgesia while reducing opioid-related side effects. The design focuses on applying a multimodal, balanced anesthesia strategy to minimize opioid exposure and associated complications such as PONV and constipation. Eligible participants are adults 18-80 with ASA II-III undergoing pancreaticoduodenal surgery and who can consent to regional anesthesia and participation. Outcomes of interest include pain control, postoperative opioid consumption, and incidence of opioid-related adverse effects.
Why it matters
Potential benefit: If successful, patients may experience less opioid use after surgery and fewer opioid-related side effects while achieving satisfactory pain relief.
How similar studies have gone: Other studies have shown reduced opioid use and comparable pain control with opioid-free or multimodal anesthesia approaches in major abdominal surgery.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-80 years * ASA II and III * Patient consent to the proposed regional anesthesia * Patient consent to participate in the study * Surgical procedure in the pancreaticoduodenal area by laparotomy Exclusion criterion * Patient refusal to participate in the study * Inability to operate the PCA pump * Lack of understanding of the NRS scale * Hypersensitivity to anesthetics * First- or second-degree heart block.
Where it's running
-
Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University
Krakow, Lesser Poland Voivodeship, Poland Recruiting
Study contacts
- Study coordinator: Tomasz Skladzien, phd md
- Email: t.skladzien@interia.pl
- Phone: +48 12 4001800
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.