Opioid Free Anaesthesia-Analgesia Strategy on Surgical Stress and Immunomodulation in Elective VATS-Lobectomy for NSCLC
RecruitingPhase 4NCT05172739
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Effect of a Perioperative Opioid Free Anaesthesia-Analgesia (OFA-A) Strategy on Surgical Stress Response and Immunomodulation in Elective VATS Lobectomy for NSCLC Lung Cancer: A Prospective Randomized Study
- Conditions
- Systemic Inflammatory Response Syndrome
- Postoperative Pain, Acute
- Postoperative Pain, Chronic
- Infections Postoperative
- Opioid Use
- Anesthesia
- Non-small Cell Lung Cancer
- Interventions
- Drug: Opioid-Based Anesthesia-Analgesia Strategy
- Drug: Opioid-free Anesthesia-Analgesia Strategy
- Sponsor
- University of Crete
- Start date
- 2021-10-01
- Primary completion
- 2025-11-01
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Greece
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * patients undergoing elective VATS lobectomy * early stage NSCLC (up to T3N1M0) Exclusion Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05172739