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Opioid-free anesthesia is not associated with greater pain than opioid anesthesia and reduces the need for opioids in the postoperative period.
Detailed Description General anesthesia using opioids is an accepted, common, and considered safe form of treatment for the patient. Opioids are associated with numerous complications, such as opioid-induced hyperalgesia (the so-called opioid paradox), and postoperative nausea, vomiting, and constipation. Modern anesthesiology, seeking alternatives to opioid-based analgesia, is increasingly turning to low-opioid and opioid-free pain management protocols. By replacing opioids with non-opioid analgesics, co-analgesics, and using regional and local anesthesia techniques, the investigators reduce or avoid the adverse effects of opioids while maintaining a satisfactory level of analgesia for the patient. Methods of administering general anesthesia without or with minimal opioid use have become particularly important in bariatric surgery, reducing the incidence of postoperative respiratory depression and excessive sedation.Opioid-free anesthesia (OFA) is a component of a multimodal, balanced general anesthesia strategy aimed at maximizing the desired analgesic effects while minimizing adverse drug reactions and side effects by utilizing the synergistic effects of various pharmacological agents in combination with regional or local anesthesia techniques. In terms of pharmacology, OFA includes opioid-free anesthesia using non-opioid analgesics - non-steroidal anti-inflammatory drugs, paracetamol, metamizole, and co-analgesics (lidocaine, magnesium, ketamine, dexmedetomidine, gabapentinoids, corticosteroids) and local anesthetics for regional anesthesia.The benefits of ketamine include improved analgesia when combined with opioids or when they are completely eliminated, a reduced incidence of chronic postoperative pain and postoperative nausea and vomiting.The additional use of lidocaine reduces pain intensity in the early postoperative period, as well as the incidence of intestinal atony, nausea and vomiting after abdominal surgery, inhibits the procedure-induced inflammatory response, and reduces the need for opioids. The group of patients to whom the OFA protocol applies includes individuals dependent on opioids, as well as patients with increased tolerance to opioids due to long-term use (pain therapy in cancer, chronic non-cancer pain). Additionally, opioids can influence the infiltration of immune cells in the tumor microenvironment and indirectly exert immunosuppressive effects, thereby participating in an additional mechanism of cancer development and escalation.Due to the increasing number of reports of cancer progression in patients undergoing surgery under general anesthesia using opioids, OFA is believed to have a favorable long-term prognostic effect, especially for oncology patients. The opioid-free protocol is also used for postoperative analgesia. It is estimated that chronic persistent postoperative pain is experienced by up to 75% of surgical patients, which has a particularly negative impact on quality of life.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 who would be anesthetized with opioids and opioid-free anesthesia (patients would be randomly assigned to one group) at 1, 2, 6, 12, 24, and 48 hours after surgery. Other secondary objectives include assessing the occurrence 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 duodenopancreatic surgery by laparotomy under balanced anesthesia including opioids |
|
| Opioid Free Anesthesia (OFA) | Experimental | Patients who will have duodenopancreatic surgery by laparotomy under balanced anesthesia including OFA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid | Other | Patients who will have duodenopancreatic surgery by laparotomy under balanced anesthesia including opioids |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | oxycodone consumption in the postoperative period | up to 48 h after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain measurment | 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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tomasz Skladzien, phd md | Contact | +48 12 4001800 | +48 | t.skladzien@interia.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 | 30688 | Poland |
Individual 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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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000701 | Analgesics, Opioid |
| ID | Term |
|---|---|
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| OFA | Other | Patients who will have duodenopancreatic surgery by laparotomy under balanced anesthesia including OFA |
|
ponv and vomiting occurence
| 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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |