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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-06

Study Completion Date

2027-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Chronic Postsurgical Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Oliceridine group

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.

Group Type EXPERIMENTAL

Oliceridine

Intervention Type DRUG

postoperative patient-controlled analgesia (PCA)

Sufentanil Group

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.

Group Type ACTIVE_COMPARATOR

Sufentanil

Intervention Type DRUG

Sufentanil

Interventions

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Oliceridine

postoperative patient-controlled analgesia (PCA)

Intervention Type DRUG

Sufentanil

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No