Opioid Free Anaesthesia-Analgesia Strategy on Surgical Stress and Immunomodulation in Elective VATS-Lobectomy for NSCLC

Recruiting now · Phase 4

Conditions studied: Systemic Inflammatory Response Syndrome, Postoperative Pain, Acute, Postoperative Pain, Chronic, Infections Postoperative, Opioid Use, Anesthesia, Non-small Cell Lung Cancer

In brief

Lobectomy is a major, high-risk surgical procedure that in addition to one-lung ventilation (OLV) exerts a potent surgical stress response. An overwhelming immune cell recruitment may lead to excessive tissue damage, peripheral organ injury and immunoparesis. The effect of anesthesia on the immune system is modest, compared to the effects induced by major surgery. However, to an immunocompromised patient, due to cancer and/or other comorbidities, the immunosuppressive effects of anesthesia may increase the incidence of post-operative infections, morbidity, and mortality. Exogenous opioids have been correlated with immunosuppression, opioid-induced hyperalgesia, and respiratory depression, with deleterious outcomes. An Opioid-Free Anaesthesia-Analgesia (OFA-A) strategy is based on the administration of a variety of anaesthetic/analgesic and other pharmacological 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, will lead to an attenuated surgical stress response and attenuated immunosuppression, compared to a conventional Opioid-Based Anaesthesia-Analgesia (OBA-A) strategy. The aforementioned effects, are presumed to be associated with equal or improved analgesia and decreased incidence of postoperative infections compared to a perioperative OBA-A technique.

Key facts

Study ID

NCT05172739

Run by

University of Crete

People needed

70

Starts

2021-10-01

Expected to finish

2026-11-01

Last updated by the study team

2021-12-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• patients undergoing elective VATS lobectomy
• early stage NSCLC (up to T3N1M0)

You may not qualify if…

• Immunocompromised patients
• previous lung surgery
• preoperative corticosteroid or immunosuppressive drug use
• uncontrolled Diabetes Mellitus
• cardiac failure (NYHA 3 and 4)
• preoperative infection (CRP >5mg/ml, WBC >10x10\^9/L)
• preoperative anemia (Hb<12g/dl)
• chronic inflammatory diseases
• inflammatory bowel disease
• Group-specific exclusion criteria:
• OFA-Α: perioperative opioid administration, within the study period
• OBA-Α: perioperative dexmedetomidine or lidocaine infusion, ketamine, gabapentinoid or corticosteroid administration within the study period

Where it is running

• University of Crete — Heraklion, Crete, Greece (enrolling)

Full record on ClinicalTrials.gov

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