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Comparison of the Efficacy and Safety of Intravenous Buprenorphine Administered Via PCA System Versus Oxycodone in the Management of Postoperative Pain After Video-Assisted Thoracoscopic Surgery

RecruitingPhase 4Ages 18 Years - 75 YearsAllMedical University of Silesia
NCT07434427 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn whether intravenous buprenorphine administered via a patient-controlled analgesia (PCA) system provides effective and safer postoperative pain control than intravenous oxycodone PCA in adults undergoing video-assisted thoracoscopic surgery (VATS). It will also evaluate the overall tolerability of buprenorphine in the early postoperative period and explore longer-term pain outcomes. The main questions it aims to answer are: Does buprenorphine PCA provide pain control that meets predefined targets during the first 48 hours after VATS (both at rest and during respiratory rehabilitation/mobilization), compared with oxycodone PCA? Does buprenorphine PCA reduce clinically relevant respiratory safety events (e.g., apnea or oxygen desaturation requiring intervention) and excessive sedation, compared with oxycodone PCA? What opioid-related adverse effe

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📋 Eligibility rules (as published)
Inclusion Criteria: * qualification for elective thoracic surgery performed using the VATS technique, physical status ASA I-III, anticipated use of PCA in the postoperative period, patient's consent to participate in the study. Exclusion Criteria: * inability to provide informed consent, * hypersensitivity to opioids or study medications, * chronic opioid therapy, * previously diagnosed chronic pain, * chronic use of analgesic medications, * disorders of consciousness preventing appropriate use of the PCA pump, * severe renal or hepatic insufficiency, * pregnancy or breastfeeding, * clinically relevant drug interactions (rifampicin, carbamazepine, CYP3A4 inhibitors).
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What it tests

  • Group B (Buprenorphine)
  • Group O (Oxycodone)
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Where

1 site
Clinical Hospital No 1
Zabrze, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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