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 4NCT07434427
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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)
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 effects (e.g., nausea/vomiting, pruritus, constipation, hypotension) occur with buprenorphine PCA versus oxycodone PCA? Does buprenorphine PCA affect time to first patient-initiated analgesic demand and total opioid consumption within 48 hours? Does the choice of PCA opioid influence quality of recovery and the incidence of persistent postoperative pain at follow-up? Researchers will compare buprenorphine PCA to oxycodone PCA (both as part of standardized multimodal analgesia and perioperative care, including serratus anterior plane block) to determine whether buprenorphine provides non-inferior analgesia with a superior safety profile. Participants will: Be randomly assigned (double-blind) to receive buprenorphine PCA or oxycodone PCA for 48 hours after surgery, alongside standard multimodal analgesia Receive standardized general anesthesia for VATS with one-lung ventilation and an ultrasound-guided serratus anterior plane block at the end of surgery Have pain scores (NRS) recorded at multiple time points over 48 hours, at rest and during rehabilitation, and complete recovery questionnai…
Study details
- Official title
- 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 - A Prospective, Randomized Clinical Trial
- Conditions
- Acute Postoperative Pain
- Chronic Postoperative Pain
- Toracosurgery
- Video-assisted Thoracis Surgery (VATS)
- Interventions
- Drug: Group B (Buprenorphine)
- Drug: Group O (Oxycodone)
- Sponsor
- Medical University of Silesia
- Start date
- 2026-03-18
- Primary completion
- 2027-05
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- Poland
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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).
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07434427