Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University
Krakow, Lesser Poland Voivodeship, 30-688, Poland
NCT Number: NCT07378189
Opioid-free anesthesia is not associated with greater pain than opioid anesthesia and is associated with reduced postoperative pain.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Krakow, Lesser Poland Voivodeship, 30-688, Poland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients who will have pancreatic operation under Opioid Free anesthesia
Patients who will hav pancreatic operation under balanced anesthesia including opioids
Time frame: up to 48 hours after surgery
measurement of total oxycodone consumption in the postoperative period
Time frame: at 1, 2, 6, 12, 24, and 48 hours after surgery
Assessment of pain at 1, 2, 6, 12, 24, and 48 hours after surgery by NRS scale (0-10, 0 - no pain, 10 worst pain imaginable)
Time frame: up to 48 h after surgery
assessment of the occurrence of postoperative nausea and vomiting (PONV)
Time frame: on the 7th day after surgery
QOR-15 questionnaire to assess quality of life and PQA-10 questionnaire. The QOR-15 is a 15 items questionnaire which provides a valid and efficient evaluation of the postoperative quality of recovery.
The QoR 15 score is a score of 15 items, each scored from 0 to 10. These items assess 5 dimensions of post-operative recovery: pain, physical comfort, functional autonomy, emotions and psychological support.
These 15 items represent the quality of post-operative rehabilitation in its physical and mental dimensions
Contact information is provided by the study sponsor or research team.
Jagiellonian University
Other
Acronym: OFAPP
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