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

Tianjin Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: Chronic Postsurgical Pain

Treatments: Drug: Sufentanil; Drug: Oliceridine

Study type: Interventional

Funder types: Other

Identifiers

NCT07018375

IRB2025-YX-199-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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320 participants in 2 patient groups

Oliceridine group

Experimental group

Description:

Administer a loading dose of 0.03 mg/kg intravenously 20-30 minutes before the end of surgery. Postoperative PCA pump configuration: 0.6 mg/kg oxycodone 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.

Treatment:

Drug: Oliceridine

Sufentanil Group

Active Comparator group

Description:

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.

Treatment:

Drug: Sufentanil