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A Study on the Efficacy and Safety of Tegileridine Fumarate for Postoperative Analgesia after Thoracoscopic Surgery—A Single-Center, Double-Blind, Randomized Controlled Clinical Trial

A Study on the Efficacy and Safety of Tegileridine Fumarate for Postoperative Analgesia after Thoracoscopic Surgery—A Single-Center, Double-Blind, Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113764
Enrollment
Unknown
Registered
2025-12-03
Start date
2025-12-03
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain

Interventions

Control group:Postoperative analgesia using morphine
Experimental group:Postoperative analgesia using tegileridine fumarate

Sponsors

Henan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Understand the trial, comprehend and be able to cooperate with its procedures, have good communication skills, voluntarily participate, and sign the written informed consent form; 2. Aged 18-65 years, any gender; 3. Body Mass Index (BMI) between 18.0 kg/m^2 and 28.0 kg/m^2; 4. American Society of Anesthesiologists (ASA) classification I to II; 5. Scheduled for thoracoscopic surgery under general anesthesia, with an expected surgery duration of 1 to 6 hours.

Exclusion criteria

Exclusion criteria: 1. Allergic to opioids or nonsteroidal anti-inflammatory drugs, or having contraindications to them; 2. Severe liver or kidney dysfunction (Child-Pugh class C, or eGFR 10 mg/day of oxycodone, continuously >2 weeks) or psychiatric medications; 5. History of substance abuse (drugs or alcohol); 6. Pregnant or breastfeeding women; 7. Participation in other drug clinical trials within the past 3 months; 8. Other conditions deemed unsuitable for participation in this study by the investigator.

Design outcomes

Primary

MeasureTime frame
Postoperative pain score (NRS);

Secondary

MeasureTime frame
Remedial analgesia;PCA pump dosage and effective number of pump presses;Anxiety, depression and sleep quality assessment;Postoperative recovery;Adverse events;

Countries

China

Contacts

Public ContactZhang Jiaqiang

Henan Provincial People's Hospital (Zhengzhou University People's Hospital)

hnmzxh@163.com+86 371 6558 0445

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026