Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
ID05172739

Effect of Perioperative Opioid-Free vs Opioid-Based Anaesthesia-Analgesia on Surgical Stress and Immune Response in Elective VATS Lobectomy for NSCLC

Led by University of Crete · Updated on 2021-12-29

70

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of an Opioid-Free Anaesthesia-Analgesia (OFA-A) strategy compared to a conventional Opioid-Based Anaesthesia-Analgesia (OBA-A) approach in patients undergoing elective video-assisted thoracoscopic surgery (VATS) lobectomy for early stage non-small cell lung cancer (NSCLC). The study focuses on how these anesthesia methods influence surgical stress response, immune system modulation, and postoperative infections due to the high surgical stress and immunosuppression caused by lobectomy and one-lung ventilation. The trial is a prospective randomized study sponsored by the University of Crete. Two anesthesia strategies will be compared: the conventional Opioid-Based method using drugs like midazolam, propofol, fentanyl, morphine, and others, and the Opioid-Free approach which uses a combination of agents including pregabalin, dexmedetomidine, lidocaine, ketamine, magnesium sulphate, and dexamethasone among others. Both include premedication, anesthesia induction and maintenance, wound infiltration, and postoperative analgesia with patient-controlled analgesia pumps using different drug combinations. Rescue therapy with tramadol is available if needed. Participants will undergo various blood tests before surgery, at the end of surgery, and 24 hours after to measure markers of inflammation and immune response, such as interleukins, tumor necrosis factor, C-reactive protein, and white blood cell counts. Hemodynamic stability will be monitored continuously during surgery. Postoperative pain will be assessed daily for three days using multiple pain scales, and pulmonary complications will be tracked for five days. Chronic pain will be evaluated three months after surgery. The total duration of participation includes surgery and follow-up assessments over several months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing elective VATS lobectomy
  • Early stage non-small cell lung cancer (up to T3N1M0)
  • Age between 18 and 80 years
  • Both males and females
Not Eligible

You will not qualify if you...

  • Immunocompromised patients
  • Previous lung surgery
  • Use of corticosteroids or immunosuppressive drugs before surgery
  • Uncontrolled diabetes mellitus
  • Cardiac failure classified as NYHA 3 or 4
  • Preoperative infection with CRP >5 mg/ml or WBC >10x10^9/L
  • Preoperative anemia with hemoglobin <12 g/dl
  • Chronic inflammatory diseases
  • Inflammatory bowel disease
  • Group-specific exclusions: For opioid-free anesthesia group, perioperative opioid administration is not allowed
  • For opioid-based anesthesia group, perioperative use of dexmedetomidine, lidocaine infusion, ketamine, gabapentinoids, or corticosteroids is not allowed

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Perioperative period including surgery and immediate postoperative days

Participants undergo elective VATS lobectomy for non-small cell lung cancer and receive either an opioid-based or opioid-free anesthesia-analgesia strategy during the perioperative period.

1 day of surgery plus approximately 3 postoperative days of analgesic management

Follow-up

Duration - Up to 3 months after surgery

Participants are monitored for acute postoperative pain, pulmonary complications, and chronic postoperative pain up to three months after surgery.

Daily assessments during the first 5 postoperative days and 1 visit at 3 months

Trial Site Locations

Total: 1 location

1

University of Crete

Heraklion, Crete, Greece, 71110

Actively Recruiting

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Research Team

P

Periklis Vasilos, MD

G

Georgios Stefanakis, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Published Research Related To This Trial

Role of surgical manipulation in lung inflammatory response in a model of lung resection surgery.

Guillermo Sánchez-Pedrosa, Elena Vara Ameigeiras, Javier Casanova Barea...

https://pubmed.ncbi.nlm.nih.gov/29945217

Opioid-induced immunosuppression and carcinogenesis promotion theories create the newest trend in acute and chronic pain pharmacotherapy.

Urszula Kosciuczuk, Pawel Knapp, Anna Maria Lotowska-Cwiklewska

https://pubmed.ncbi.nlm.nih.gov/32215455