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Opioid-free anesthesia is not associated with greater pain than opioid anesthesia and is associated with reduced postoperative pain.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balanced anesthesia with opioids | Active Comparator | Patients who will have pancreatic operation under balanced anesthesia including opioids |
|
| Opioid Free Anesthesia (OFA) | Experimental | Patients who willl have pancreatic operation under Opioid Free anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid Free Anesthesia (OFA) | Other | Patients who will have pancreatic operation under Opioid Free anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | measurement of total oxycodone consumption in the postoperative period | up to 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessment | 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) | at 1, 2, 6, 12, 24, and 48 hours after surgery |
| PONV |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michal Cicio, MD | Contact | 124001800 | +48 | michal.cicio@uj.edu.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University | Krakow | Lesser Poland Voivodeship | 30-688 | Poland |
ndividual participant data (IPD) will be shared contingent upon obtaining appropriate consent from the study participants. Data will be made available only in accordance with applicable ethical and regulatory requirements.
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| Balanced anesthesia with opioids | Drug | Patients who will hav pancreatic operation under balanced anesthesia including opioids |
|
assessment of the occurrence of postoperative nausea and vomiting (PONV)
| up to 48 h after surgery |
| Quality Of Recovery | 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 | on the 7th day after surgery |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D058126 | Balanced Anesthesia |
| D000701 | Analgesics, Opioid |
| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
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