NCT07018375

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for phase_4

Timeline
12mo left

Started Jan 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Jan 2026Apr 2027

First Submitted

Initial submission to the registry

May 27, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

January 6, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

May 27, 2025

Last Update Submit

January 5, 2026

Conditions

Chronic Postsurgical Pain

Outcome Measures

Primary Outcomes (1)

  • Incidence of chronic pain after surgery

    Chronic pain intensity was assessed by a numeric rating scale (NRS) using a telephone questionnaire

    from day 1 to day 90 after surgery

Secondary Outcomes (9)

  • postoperative acute pain NRS scoring

    24h and 48h after surgery

  • Incidence of adverse events

    48 hours after surgery

  • Chronic pain NRS score 3 months after surgery

    3 months postoperatively

  • Neuropathic pain (DN4 score ≥ 4)

    1 day preoperatively；3 months postoperatively

  • Sleep quality assessment

    1 day preoperatively；3 months postoperatively

  • +4 more secondary outcomes

Study Arms (2)

Oliceridine group

EXPERIMENTAL

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.

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

OliceridineDRUG

postoperative patient-controlled analgesia (PCA)

Oliceridine group
SufentanilDRUG

Sufentanil

Sufentanil Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Interventions

((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amineSufentanil

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Yang Jiao, Doctor

    Tianjin Medical University General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Jiao, Doctor

CONTACT

+86 159 0029 2506jiaoxiuxiu1987@163.com

Yonghao Yu, Doctor

CONTACT

yuyonghaoemail@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
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

January 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share