RecruitingPhase 4NCT04894864

Opioid Free Anesthesia-Analgesia Strategy and Surgical Stress in Elective Open Abdominal Aortic Aneurysm Repair

Effect of a Perioperative Opioid Free Anesthesia-Analgesia (OFA-A) Strategy on Surgical Stress Response in Elective Open Abdominal Aortic Aneurysm Repair: A Prospective Randomized Study


Sponsor

University of Crete

Enrollment

40 participants

Start Date

Oct 8, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Open Abdominal Aortic Aneurysm (AAA) repair is a high-risk surgical procedure accompanied by intense endocrine and metabolic responses to surgical stress, with subsequent activation of the inflammatory cascade, cytokine and acute-phase protein release, and bone marrow activation. There is a proven correlation of surgical stress, which patients undergoing open AAA repair are subjected to, with patient outcome, morbidity/mortality, intensive care unit stay and overall length of stay. Modern general anesthetic techniques have been revised and rely on perioperative multimodal anesthetic and analgesic strategies for improved overall patient outcome. Based on this context of a multimodal anesthetic technique and having taken into consideration the international "opioid-crisis" epidemic, an Opioid Free Anesthesia-Analgesia (OFA-A) strategy started to emerge. It is based on the administration of a variety of anesthetic/analgesic agents with different mechanisms of action, including immunomodulating and anti-inflammatory effects. Our basic hypothesis is that the implementation of a perioperative multimodal OFA-A strategy, involving the administration of pregabalin, ketamine, dexmedetomidine, lidocaine, dexamethasone, dexketoprofen, paracetamol and magnesium sulphate, will lead to attenuation of surgical stress response compared to a conventional Opioid-Based Anesthesia-Analgesia (OBA-A) strategy. Furthermore, the anticipated attenuation of the inflammatory response, is pressumed to be associated with equal or improved analgesia, compared to a perioperative OBA-A technique.


Eligibility

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing an opioid-free approach to anesthesia and pain relief to a standard approach in patients undergoing planned open surgery to repair an abdominal aortic aneurysm (a dangerous bulge in the main abdominal blood vessel). Opioids can have significant side effects; this study tests whether avoiding them reduces the surgical stress response and improves recovery. You may be eligible if: • You are between 40 and 85 years old • You are scheduled for elective (planned, non-emergency) open surgery to repair an infrarenal abdominal aortic aneurysm • You have given informed consent to participate You may NOT be eligible if: • You have a weakened immune system • You have an active infection • You are having a repeat operation on your aorta • You have inflammatory bowel disease or a chronic inflammatory condition (e.g., rheumatoid arthritis) • You have cancer • You take chronic corticosteroids or immunosuppressants • You are expected to need more than 2 units of blood transfusion during surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOpioid-Based Anesthesia-Analgesia Strategy

A perioperative Opioid-Based multimodal Anesthesia-Analgesia strategy will be implemented as described in the Opioid-Based arm of the study.

DRUGOpioid-free Anesthesia-Analgesia Strategy

A perioperative Opioid-Free multimodal Anesthesia-Analgesia strategy will be implemented as described in the Opioid-Free arm of the study.


Locations(1)

University of Crete

Heraklion, Crete, Greece

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NCT04894864


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