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NCT Number: NCT07018375

Effect of Oliceridine Patient-Controlled Intravenous Analgesia on Postoperative Chronic Pain After Video-Assisted Thoracoscopic Lung Resection

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The No. 2 Hospital of Baoding, Baoding, Hebei, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ① 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 cancer;
  • Preoperative pain score <1 on the Numeric Rating Scale (NRS);
  • Ability to understand the study objectives and procedures, with voluntary informed consent obtained;
  • Expected postoperative recovery in the general ward setting.

Exclusion criteria

  • ① History of chronic pain or long-term analgesic use prior to surgery;
  • Previous ipsilateral thoracic surgery or conversion to thoracotomy;
  • 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/1.73m²);
  • Concurrent malignancy or active infection;
  • diagnosed psychiatric disorders or communication barriers precluding study participation;
  • Known hypersensitivity to study medications (opioids, adjuvant analgesics, anesthetics, or antiemetics);
  • Pregnancy, lactation, or planned pregnancy during the study period
  • Any condition deemed unsuitable for study participation by the investigator

Treatment and study plan

Oliceridine

Drug

postoperative patient-controlled analgesia (PCA)

Sufentanil

Drug

Sufentanil

Primary outcomes

  1. Incidence of chronic postsurgical pain with functional impact at 3 months after surgery

    Time frame: At 3 months after surgery (assessment window: postoperative day 90 +/- 14 days)

    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.

Secondary outcomes

  1. Postoperative acute pain NRS score

    Time frame: 24h and 48h after surgery

    Acute pain NRS score at 24 and 48 hours after surgery

  2. Quality of Recovery-15 (QoR-15) score

    Time frame: 24h and 48h after surgery

    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.

  3. Cumulative PCA opioid consumption and bolus deliveries

    Time frame: 0-48 hours postoperatively

    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.

  4. Incidence of opioid-related adverse events

    Time frame: 0-48 h postoperatively

    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.

  5. Use and frequency of rescue analgesic administration

    Time frame: 0-48h postoperatively, 1 month postoperatively, 3 months postoperatively

    Dose and frequency of rescue analgesics

  6. Brief Pain Inventory-Short Form (BPI-SF) pain severity and pain interference scores

    Time frame: 1 month postoperatively, 3 months postoperatively

    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.

  7. Incidence of neuropathic pain component (DN4i ≥ 4)

    Time frame: 1 month postoperatively, 3 months postoperatively

    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.

  8. Sleep quality assessment

    Time frame: 1 day preoperatively(baseline), 1 month postoperatively, 3 months postoperatively

    By the Pittsburgh Sleep Quality Index (PSQI)

  9. Psychological status assessment

    Time frame: 1 day preoperatively(baseline), 1 month postoperatively, 3 months postoperatively

    By Hospital Anxiety and Depression Scale(HADS)

  10. Pain catastrophizing level

    Time frame: 1 day preoperatively(baseline), 1 month postoperatively, 3 months postoperatively

    By the Pain Catastrophizing Scale (PCS)

  11. Quality of life assessment

    Time frame: 1 day preoperatively(baseline), 3 months postoperatively

    The 36-Item Short Form Survey (SF-36)

Study contacts

Contact information is provided by the study sponsor or research team.

Yang Jiao, Doctor

CONTACT

[email protected]

+86 159 0029 2506

Yonghao Yu, Doctor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Tianjin Medical University General Hospital

Other

Collaborators

  • Haibin People's Hospital of Tianjin Binhai New Area
  • North China University of Science and Technology
  • The No. 2 Hospital of Baoding
  • The People's Hospital of Jizhou District, Tianjin
  • Tianjin Cancer Hospital Airport Hospital
  • Tianjin Medical University Second Hospital

Registry information

Official study title

Effect of Oliceridine-based Intravenous Patient-Controlled Analgesia on Chronic Postsurgical Pain After Video-Assisted Thoracoscopic Lung Resection: A Multicenter Randomized Double-Blind Controlled Trial Protocol

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 12, 2025
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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