Pain Management
Conditions
Keywords
Pain, OFA, Opioid Free Anesthesia
Brief summary
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
OTHEROpioid Free Anesthesia (OFA)
Patients who will have pancreatic operation under Opioid Free anesthesia
DRUGBalanced anesthesia with opioids
Patients who will hav pancreatic operation under balanced anesthesia including opioids
Sponsors
Jagiellonian University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | up to 48 hours after surgery | measurement of total oxycodone consumption in the postoperative period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment | 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) |
| PONV | up to 48 h after surgery | assessment of the occurrence of postoperative nausea and vomiting (PONV) |
| Quality Of Recovery | 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 |
Countries
Poland
Contacts
CONTACTMichal Cicio, MD
Outcome results
None listed