The primary objective is to evaluate the impact of oliceridine versus sufentanil for perioperative analgesia on the incidence of chronic postsurgical pain (CPSP) with functional impact in patients undergoing video-assisted thoracoscopic surgery.
Age 18-75 years
ASA physical status I-III
BMI 18-35 kg/m²
Scheduled for unilateral video-assisted thoracoscopic surgery (VATS) lung resection, including wedge resection, segmentectomy, lobectomy, or radical resection for lung cancerresection for lung cancer
History of chronic pain or long-term analgesic use prior to surgery
Previous ipsilateral thoracic surgery
Prior neoadjuvant radiotherapy or chemotherapy
Severe cardiovascular or cerebrovascular disease, or hepatic/renal dysfunction (ALT/AST > 3 × upper limit of normal; eGFR < 60 mL/min/1.73 m²)
Parallel
Oliceridine
Drugpostoperative patient-controlled analgesia (PCA)
Sufentanil
DrugSufentanil
Incidence of chronic postsurgical pain with functional impact at 3 months after surgery
CPSP is a composite binary endpoint, positive only when all three criteria are met: (1) pain related to thoracoscopic surgery, confirmed by the scripted question "Do you currently have persisting pain related to your thoracoscopic surgery?", localized to the surgical site or a referred area, present for at least 3 months, and not attributable to other causes (local infection, tumour recurrence, or a new surgical or medical condition); (2) average numeric rating scale (NRS) pain score \>= 1 (0-10) at the surgical site during the week preceding the assessment; and (3) pain-related functional interference, defined as a pain interference score \>= 1 on the Brief Pain Inventory-Short Form (validated Chinese version), calculated as the mean of 7 interference items (each 0-10; prorated mean if at least 4 of 7 items are completed), with a 1-week recall period.
Postoperative acute pain NRS score
Acute pain intensity at 24 and 48 hours after surgery, measured by the Numeric Rating Scale (NRS), which ranges from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate worse outcomes (greater pain intensity).
Quality of Recovery-15 (QoR-15) score
The QoR-15 assesses postoperative recovery quality across 15 items (0-10 each; total 0-150), administered at the bedside. Higher scores indicate better recovery.
Cumulative PCA opioid consumption and bolus deliveries
Total delivered volume of the study solution (mL) and number of bolus deliveries (attempted and successful) recorded by the PCA pump during the 48-hour intervention period. Delivered oliceridine and sufentanil doses will be derived from body weight-based concentrations. The cumulative 24-hour oliceridine dose will be documented against the 27 mg/day threshold specified in the prescribing information.
Incidence of opioid-related adverse events
Incidence of opioid-related adverse events (ORAEs) within 48 hours postoperatively, including: postoperative nausea and vomiting (PONV), respiratory depression (SpO₂ \<92% or respiratory rate \<8/min), pruritus, sedation (Ramsay Sedation Scale ≥4), and dizziness.
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Tianjin Medical University General Hospital
Lead sponsor
The No. 2 Hospital of Baoding
Collaborator
Tianjin Cancer Hospital Airport Hospital
Collaborator
Tianjin Medical University Second Hospital
Collaborator
North China University of Science and Technology
Collaborator
Haibin People's Hospital of Tianjin Binhai New Area
Collaborator
The People's Hospital of Jizhou District, Tianjin
Collaborator
