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

NCT07434427 | Not Yet Recruiting Phase 4

• 1 other identifier: BUPRE-OXY
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 questionnaires (QoR-15) early after surgery Be monitored regularly for vital signs, sedation level (RASS), respiratory events, and other adverse effects, with total opioid use recorded Provide satisfaction ratings at discharge and be followed after discharge to assess persistent postoperative pain/hyperalgesia at 1, 3, and 6 months

Conditions

Acute Postoperative Pain; Chronic Postoperative Pain; Toracosurgery; Video-assisted Thoracis Surgery (VATS)

Keywords

pain; acute postoperative pain; chronic postoperative pain

Outcome Measures

Primary Outcomes (1)

• Efficacy of intravenous buprenorphine administered via a PCA system.

  The primary endpoint will be the comparative evaluation of the efficacy and safety of intravenous buprenorphine administered via a PCA system as part of multimodal analgesia following VATS procedures, expressed by: achieving effective postoperative pain control, defined as a mean NRS score - Numeric Pain Rating Scale (from 0 to 10 points of Units on a Scale). Expected outcome: comparable or lower NRS scores in the buprenorphine group across all time points

  First 48 hours after surgery.

Secondary Outcomes (5)

• Respiratory safety.

  First 48 hours after surgery.

• Pain Intensity

  At 2, 6, 12, 24, and 48 hours, 3 months and 6 months after surgery.

• Time to First Patient-Initiated Analgesic Dose and Cumulative Opioid Consumption

  First 12 hours after anesthesia.

• Total opioid dose administered.

  48 hours postoperatively

• Quality Of Recovery

  Day 1 and 3, 3 months and 6 months after surgery

Study Arms (2)

Group O (Oxycodone)

ACTIVE COMPARATOR

Group O (Oxycodone) Intravenous oxycodone administered via PCA pump (40 mg / 40 ml 0.9% NaCl): bolus dose: 1 mg (1 ml solution), lockout interval: 15 minutes, maximum hourly dose: 4 mg, maximum daily dose: 96 mg.

Drug: Group O (Oxycodone)

Group B (Buprenorphine)

EXPERIMENTAL

Intravenous buprenorphine administered via PCA pump (1 mg / 50 ml 0.9% NaCl): bolus dose: 0.02 mg (1 ml solution), lockout interval: 15 minutes, maximum hourly dose: 0.08 mg, maximum potential daily dose: 1.92 mg.

Drug: Group B (Buprenorphine)

Interventions

Group B (Buprenorphine) DRUG

Intravenous buprenorphine administered via PCA pump (1 mg / 50 ml 0.9% NaCl): bolus dose: 0.02 mg (1 ml solution), lockout interval: 15 minutes, maximum hourly dose: 0.08 mg, maximum potential daily dose: 1.92 mg.

Group B (Buprenorphine)

Group O (Oxycodone) DRUG

Intravenous oxycodone administered via PCA pump (40 mg / 40 ml 0.9% NaCl): bolus dose: 1 mg (1 ml solution), lockout interval: 15 minutes, maximum hourly dose: 4 mg, maximum daily dose: 96 mg.

Group O (Oxycodone)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical University of Silesia: lead

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Buprenorphine; Oxycodone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Codeine; Morphine Derivatives

Study Officials

• Piotr Palaczyński

  Department of Anaesthesiology and Critical Care, School of Medicine with Division of Dentistry in Zabrze, Medical University of Silesia, Zabrze, Poland.

  STUDY DIRECTOR

Central Study Contacts

Justyna K Danel, Medical Doctor

CONTACT

+48 514 429 489; justyna.danel@gmail.com

Piotr Palaczyński, Doctor of Medicine

CONTACT

piotrpalaczynski@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 25, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share