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

NCT07018375 | Recruiting Phase 4 DMC

• 1 other identifier: IRB2025-YX-199-01
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 7

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) with functional impact in patients undergoing video-assisted thoracoscopic surgery.

Conditions

Chronic Postsurgical Pain

Keywords

oliceridine; sufentanil; chronic postsurgical pain; VATS; patient-controlled analgesia

Outcome Measures

Primary Outcomes (1)

• Incidence of chronic postsurgical pain with functional impact at 3 months after surgery

  CPSP is a composite binary endpoint, positive only when all three criteria are met: (1) pain related to thoracoscopic surgery, confirmed by the scripted question "Do you currently have persisting pain related to your thoracoscopic surgery?", localized to the surgical site or a referred area, present for at least 3 months, and not attributable to other causes (local infection, tumour recurrence, or a new surgical or medical condition); (2) average numeric rating scale (NRS) pain score \>= 1 (0-10) at the surgical site during the week preceding the assessment; and (3) pain-related functional interference, defined as a pain interference score \>= 1 on the Brief Pain Inventory-Short Form (validated Chinese version), calculated as the mean of 7 interference items (each 0-10; prorated mean if at least 4 of 7 items are completed), with a 1-week recall period.

  At 3 months after surgery (assessment window: postoperative day 90 +/- 14 days)

Secondary Outcomes (11)

• Postoperative acute pain NRS score

  24h and 48h after surgery

• Quality of Recovery-15 (QoR-15) score

  24h and 48h after surgery

• Cumulative PCA opioid consumption and bolus deliveries

  0-48 hours postoperatively

• Incidence of opioid-related adverse events

  0-48 h postoperatively

• Use and frequency of rescue analgesic administration

  0-48h postoperatively, 1 month postoperatively, 3 months postoperatively

Study Arms (2)

Oliceridine group

EXPERIMENTAL

Administer a loading dose of 0.02 mg/kg intravenously 20-30 minutes before the end of surgery. Postoperative PCA pump configuration: 0.4 mg/kg oliceridine 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. The cumulative oliceridine dose should not exceed 27 mg per 24 hours, in accordance with the FDA prescribing information.

Drug: Oliceridine

Sufentanil group

ACTIVE COMPARATOR

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.

Drug: Sufentanil

Interventions

Oliceridine DRUG

postoperative patient-controlled analgesia (PCA)

Oliceridine group

Sufentanil DRUG

Sufentanil

Sufentanil group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• ASA physical status I-III
• BMI 18-35 kg/m²
• Scheduled for unilateral video-assisted thoracoscopic surgery (VATS) lung resection, including wedge resection, segmentectomy, lobectomy, or radical resection for lung cancerresection for lung cancer
• Preoperative Numeric Rating Scale (NRS) pain score of 0
• Ability to understand the study objectives and procedures, with voluntary informed consent obtained
• Expected postoperative recovery in the general ward setting

You may not qualify if:

• 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/1.73 m²)
• Severe or unstable psychiatric disorders requiring psychoactive medication (e.g., schizophrenia, bipolar disorder), or cognitive impairment precluding reliable self-report
• Other concurrent active malignancy or active infection
• Known hypersensitivity to study medications (opioids, adjuvant analgesics, anesthetics, or antiemetics)
• Pregnancy, lactation, or planned pregnancy during the study period
• Participation in another interventional clinical trial within 3 months before enrolment
• Any condition deemed unsuitable for study participation by the investigator

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead
• Tianjin Cancer Hospital Airport Hospital: collaborator
• Tianjin Medical University Second Hospital: collaborator
• North China University of Science and Technology: collaborator
• Haibin People's Hospital of Tianjin Binhai New Area: collaborator
• The People's Hospital of Jizhou District, Tianjin: collaborator
• The No. 2 Hospital of Baoding: collaborator

Study Sites (7)

The No. 2 Hospital of Baoding

Baoding, Hebei, China

RECRUITING

North China University of Science and Technology Affiliated Hospital

Tangshan, Hebei, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, 300052, China

RECRUITING

Haibin People's Hospital of Tianjin Binhai New Area

Tianjin, China

RECRUITING

The People's Hospital of Jizhou District, Tianjin

Tianjin, China

RECRUITING

The Second Hospital of Tianjin Medical University

Tianjin, China

RECRUITING

Tianjin Cancer Hospital Airport Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine; Sufentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yang Jiao, Doctor

  Tianjin Medical University General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Jiao, Doctor

CONTACT

+86 159 0029 2506; jiaoxiuxiu1987@163.com

Yonghao Yu, Doctor

CONTACT

yuyonghaoemail@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 12, 2025
• Study Start: January 6, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available beginning 12 months and ending 36 months after publication of the primary results.
• Access Criteria: Deidentified individual participant data will be shared with researchers who provide a methodologically sound proposal (including study purpose and analysis plan) approved by the study steering committee. Requests should be directed to the corresponding author (jiaoxiuxiu1987@163.com).

Locations

CN (7)