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Enrolling by Invitation

NCT Number: NCT07018375

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

The primary objective is to evaluate the impact of oliceridine versus sufentanil for perioperative analgesia on the incidence of chronic postsurgical pain (CPSP) 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

Tianjin Medical University General Hospital

Tianjin, 300052, China

About this study

The primary objective is to evaluate the impact of oliceridine administered via patient controlled analgesia device(PCA)versus sufentanil administered via PCA on the incidence of chronic postsurgical pain (CPSP) in patients undergoing video-assisted thoracoscopic surgery.

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 18-30 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;
  • 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;
  • Pre-existing psychiatric disorders or communication barriers precluding study participation;
  • Known hypersensitivity to study medications (opioids, adjuvant analgesics, anesthetics, or antiemetics);
  • 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 pain after surgery

    Time frame: from day 1 to day 90 after surgery

    Chronic pain intensity was assessed by a numeric rating scale (NRS) using a telephone questionnaire

Secondary outcomes

  1. postoperative acute pain NRS scoring

    Time frame: 24h and 48h after surgery

    Acute pain NRS score (rest versus cough) at 24 and 48 hours after surgery

  2. Incidence of adverse events

    Time frame: 48 hours after surgery

  3. Chronic pain NRS score 3 months after surgery

    Time frame: 3 months postoperatively

    assessed by NRS scale

  4. Neuropathic pain (DN4 score ≥ 4)

    Time frame: 1 day preoperatively;3 months postoperatively

    the DN4 questionnaire is a brief and user-friendly screening tool designed to identify the presence of neuropathic pain components

  5. Sleep quality assessment

    Time frame: 1 day preoperatively;3 months postoperatively

    By Pittsburgh Sleep Index (PSQI) scale

  6. Psychological status assessment

    Time frame: 1 day preoperatively; 3 months postoperatively

    By Hamilton Anxiety/Depression Rating Scale (HAMA/HADS)

  7. Evaluate pain catastrophizing levels in surgical patients

    Time frame: 1 day preoperatively;3 months postoperatively

    By PCS Scale

  8. Quality of Life Assessments

    Time frame: 1 day preoperatively;3 months postoperatively

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

  9. Use and frequency of rescue analgesic administration

    Time frame: 1 day preoperatively;3 months postoperatively

    Dose and frequency of rescue analgesics

Sponsors and collaborators

Lead sponsor

Tianjin Medical University General Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 12, 2025
Registry last updated
Jul 9, 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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