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Enrolling by invitation NCT07018375

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

Phase IV Interventional Chronic Postsurgical Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oliceridine, Sufentanil.
Who it may be relevant to
Registry conditions: Chronic Postsurgical Pain. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Drug Oliceridine
    postoperative patient-controlled analgesia (PCA)
  • Drug Sufentanil
    Sufentanil

Primary outcome measures

  • Incidence of chronic pain after surgery [Time frame: from day 1 to day 90 after surgery]
Secondary outcome measures (9)
  • postoperative acute pain NRS scoring [Time frame: 24h and 48h after surgery]
  • Incidence of adverse events [Time frame: 48 hours after surgery]
  • Chronic pain NRS score 3 months after surgery [Time frame: 3 months postoperatively]
  • Neuropathic pain (DN4 score ≥ 4) [Time frame: 1 day preoperatively;3 months postoperatively]
  • Sleep quality assessment [Time frame: 1 day preoperatively;3 months postoperatively]
  • Psychological status assessment [Time frame: 1 day preoperatively; 3 months postoperatively]
  • Evaluate pain catastrophizing levels in surgical patients [Time frame: 1 day preoperatively;3 months postoperatively]
  • Quality of Life Assessments [Time frame: 1 day preoperatively;3 months postoperatively]
  • Use and frequency of rescue analgesic administration [Time frame: 1 day preoperatively;3 months postoperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin Medical University General Hospital — Tianjin

Identifiers

NCT: NCT07018375 · IRB2025-YX-199-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗