Opioid-free Anesthesia as an Alternative to General Anesthesia in Patients Undergoing Laparoscopic Peripheral Pancreatic Resection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Opioid Free Anesthesia (OFA), Balanced anesthesia with opioids.
- Who it may be relevant to
- Registry conditions: Pain Management. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Opioid-free anesthesia is not associated with greater pain than opioid anesthesia and is associated with reduced postoperative pain.
Detailed description
In our study, the investigators would like to compare the measurement of total oxycodone consumption in the postoperative period in both groups and whether the use of opioid-free anesthesia would reduce opioid consumption by 30%. The secondary objective will be to assess pain in both groups during the first 48 postoperative hours in patients undergoing pancreatic surgery. Patients would be randomly assigned to anesthesia with and without opioids at 1, 2, 6, 12, 24, and 48 hours after surgery. Other secondary objectives include assessing the incidence of postoperative nausea and vomiting (PONV), adverse drug reactions, particularly cardiac arrhythmias, and the impact on persistent postoperative pain. On day 7 after surgery, each patient will receive the QOR-15 questionnaire to assess quality of life and the PQA-10 questionnaire.
Interventions
- Other Opioid Free Anesthesia (OFA)
Patients who will have pancreatic operation under Opioid Free anesthesia - Drug Balanced anesthesia with opioids
Patients who will hav pancreatic operation under balanced anesthesia including opioids
Primary outcome measures
- Opioid consumption [Time frame: up to 48 hours after surgery]
Secondary outcome measures (3)
- Pain assessment [Time frame: at 1, 2, 6, 12, 24, and 48 hours after surgery]
- PONV [Time frame: up to 48 h after surgery]
- Quality Of Recovery [Time frame: on the 7th day after surgery]
Eligibility criteria
Inclusion criteria
- Patient consent to participate in the study
- Qualified for laparoscopic peripheral pancreatic resection
- Age 18-80 years
- ASA II and III
Exclusion criteria
- Patient refusal to participate in the study
- Inability to operate a PCA pump
- Lack of understanding of the NRS scale
- Hypersensitivity to anesthetics
- First- or second-degree heart block.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Poland · 1 center
- Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University — Krakow
Identifiers
NCT: NCT07378189 · 1072.6120.146.2025