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

Phase 4

Not yet recruiting

• Conditions: Chronic Postsurgical Pain
• Interventions: Drug: Oliceridine; Drug: Sufentanil

• Registration Number: NCT07018375
• Lead Sponsor: Tianjin Medical University General Hospital

Brief Summary

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.

Study Timeline

• Study First Submitted: 2025-05-27
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-12
• Last Update Posted: 2025-06-12
• Study Start: 2025-08-01
• Primary Completion: 2027-03-31
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oliceridine group	Oliceridine	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.
Sufentanil Group	Sufentanil	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.

Primary Outcome Measures

Name	Time	Method
Incidence of chronic pain after surgery	from day 1 to day 90 after surgery	Chronic pain intensity was assessed by a numeric rating scale (NRS) using a telephone questionnaire

Secondary Outcome Measures

Name	Time	Method
Use and frequency of rescue analgesic administration	1 day preoperatively；3 months postoperatively	Dose and frequency of rescue analgesics
Evaluate pain catastrophizing levels in surgical patients	1 day preoperatively；3 months postoperatively	By PCS Scale
Quality of Life Assessments	1 day preoperatively；3 months postoperatively	The 36-Item Short Form Survey (SF-36)
postoperative acute pain NRS scoring	24h and 48h after surgery	Acute pain NRS score (rest versus cough) at 24 and 48 hours after surgery
Incidence of adverse events	48 hours after surgery
Chronic pain NRS score 3 months after surgery	3 months postoperatively	assessed by NRS scale
Neuropathic pain (DN4 score ≥ 4)	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
Sleep quality assessment	1 day preoperatively；3 months postoperatively	By Pittsburgh Sleep Index (PSQI) scale
Psychological status assessment	1 day preoperatively； 3 months postoperatively	By Hamilton Anxiety/Depression Rating Scale (HAMA/HADS)