Opioid-free anesthesia for lung surgery
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
This study is testing whether using an opioid-free anesthesia approach during lung surgery can help patients with non-small cell lung cancer feel less pain and recover better than with traditional opioid-based anesthesia.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Crete Academic / other |
| Locations | 1 site (Heraklion, Crete) |
| Trial ID | NCT05172739 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of an Opioid-Free Anaesthesia-Analgesia (OFA-A) strategy on surgical stress and immune response in patients undergoing elective VATS lobectomy for non-small cell lung cancer (NSCLC). The study compares traditional opioid-based anesthesia with an opioid-free approach that utilizes various anesthetic and analgesic agents to minimize immunosuppression and postoperative complications. By focusing on the immune response and inflammatory markers, the trial aims to determine if the OFA-A strategy can lead to better outcomes in terms of pain management and reduced risk of infections. Participants will be monitored for postoperative pain, systemic inflammatory response, and overall recovery.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for elective VATS lobectomy with early-stage NSCLC.
Not a fit: Patients who are immunocompromised or have significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and the risk of infections in patients undergoing lung surgery.
How similar studies have performed: While opioid-free anesthesia strategies are gaining interest, this specific approach in the context of lung surgery is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Heraklion, Crete
- University of Crete — Heraklion, Crete, Greece (Recruiting)
Study contacts
- Study coordinator: Periklis Vasilos, MD
- Email: p.vassilos@gmail.com
- Phone: 00306978702023
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.