A Phase 4 interventional study of Oliceridine and Sufentanil in Chronic Postsurgical Pain, sponsored by Tianjin Medical University General Hospital. Recruiting at 7 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Tianjin Medical University General Hospital · Phase 4, Interventional, and Treatment
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.
The primary objective is to evaluate the impact of oliceridine versus sufentanil administered via patient controlled intravenous analgesia (PCIA) for perioperative analgesia on the incidence of chronic postsurgical pain (CPSP) with functional impact in patients undergoing video-assisted thoracoscopic surgery. This is a multicentre, randomised, double-blind, controlled trial enrolling 320 patients across seven Chinese tertiary centres.
Exclusion Criteria:
Administer a loading dose of 0.02 mg/kg intravenously 20-30 minutes before the end of surgery. Postoperative PCA pump configuration: 0.4 mg/kg oliceridine diluted with normal saline to a total volume of 100 mL, with a background infusion rate of 2 mL/h, PCA bolus dose of 0.5 mL per injection, lockout interval of 15 minutes, and treatment duration of 48 hours. The cumulative oliceridine dose should not exceed 27 mg per 24 hours, in accordance with the FDA prescribing information.
Drug: Oliceridine
Administer a loading dose of 0.1 μg/kg intravenously 20-30 minutes before the end of surgery. Postoperative PCA pump configuration: 2 μg/kg sufentanil diluted with normal saline to a total volume of 100 mL, with a background infusion rate of 2 mL/h, PCA bolus dose of 0.5 mL per injection, lockout interval of 15 minutes, and treatment duration of 48 hours.
Drug: Sufentanil
postoperative patient-controlled analgesia (PCA)
Sufentanil
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.
Time frame: At 3 months after surgery (assessment window: postoperative day 90 +/- 14 days)
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).
Time frame: 24h and 48h after surgery
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.
Time frame: 24h and 48h after surgery
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.
Time frame: 0-48 hours postoperatively
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.
Time frame: 0-48 h postoperatively
Use and frequency of rescue analgesic administration
Dose and frequency of rescue analgesics
Time frame: 0-48h postoperatively, 1 month postoperatively, 3 months postoperatively
Brief Pain Inventory-Short Form (BPI-SF) pain severity and pain interference scores
BPI-SF pain severity (mean of 4 items) and pain interference (mean of 7 items) scores, each 0-10, administered by face-to-face interview or structured telephone interview with a 1-week recall period.
Time frame: 1 month postoperatively, 3 months postoperatively
Incidence of neuropathic pain component (DN4i ≥ 4)
The 7-item interview version of the Douleur Neuropathique 4 questionnaire (DN4i, score range 0-7) administered by structured telephone interview. DN4i \>= 4 indicates the presence of neuropathic pain components.
Time frame: 1 month postoperatively, 3 months postoperatively
Sleep quality assessment
Sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-rated questionnaire yielding a global score ranging from 0 to 21. Higher scores indicate worse outcomes (poorer sleep quality).
Time frame: 1 day preoperatively(baseline), 1 month postoperatively, 3 months postoperatively
Psychological status assessment
Anxiety and depressive symptoms assessed by the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report questionnaire with two 7-item subscales: the HADS-Anxiety subscale and the HADS-Depression subscale, each ranging from 0 to 21. Higher scores indicate worse outcomes (greater anxiety or depressive symptoms).
Time frame: 1 day preoperatively(baseline), 1 month postoperatively, 3 months postoperatively
Pain catastrophizing level
Pain catastrophizing assessed by the Pain Catastrophizing Scale (PCS), a 13-item self-report questionnaire with a total score ranging from 0 to 52. Higher scores indicate worse outcomes (higher levels of pain catastrophizing).
Time frame: 1 day preoperatively(baseline), 1 month postoperatively, 3 months postoperatively
Quality of life assessment
Quality of life assessed by the 36-Item Short Form Health Survey (SF-36), which yields 8 domain scores, each transformed to a scale of 0 to 100. Higher scores indicate better outcomes (better health-related quality of life).
Time frame: 1 day preoperatively(baseline), 3 months postoperatively
Plan to share: Yes — Deidentified individual participant data will be made available upon reasonable request to the corresponding author, following publication of the primary results, for researchers who provide a methodologically sound proposal.
Supporting information: Study protocol, Sap, Icf
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Tianjin Medical University General Hospital