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Clinical Study on the Efficacy and Safety of Teglidine Fumarate for Postoperative Analgesia in Orthopedic Surgery

Clinical Study on the Efficacy and Safety of Teglidine Fumarate for Postoperative Analgesia in Different Types of Orthopedic Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111147
Enrollment
Unknown
Registered
2025-10-27
Start date
2025-10-27
Completion date
Unknown
Last updated
2025-11-03

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

Conditions

Orthopedic surgery

Interventions

Tegileridine Fumarate Group:After surgery, patients in the Tegileridine Fumarate group receive an intravenous loading dose of 0.75 mg Tegileridine Fumarate injection, followed by PCA (patient-controll
Morphine Group:After surgery, patients in the Morphine group receive an intravenous loading dose of 0.08 mg/kg morphine, followed by PCA (patient-controlled analgesia) configured as follows: concentra

Sponsors

Ningbo Medical Center Lihuili Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18–75 years, either sex; 2. Adult patients with ASA physical status classification I–III; 3. Scheduled for elective unilateral TKA, THA, or 1–2-level spinal fusion surgery; 4. Expected postoperative hospital stay >= 3 days to facilitate observation and follow-up; 5. Able to understand the study content and voluntarily sign the written informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of allergy or severe adverse reaction to opioids or study drug; 2. Severe hepatic or renal impairment (Child-Pugh class C, or creatinine clearance 3 months) or history of opioid abuse; 6. Presence of severe psychiatric disorder, psychological impairment, or cognitive dysfunction affecting compliance or cooperation; 7. Other conditions deemed unsuitable for participation in this trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Assessment of pain intensity at different postoperative time points;Cumulative analgesic consumption;Total and effective number of PCA presses;

Secondary

MeasureTime frame
Time to first achieve adequate analgesia (VAS = 4]);Functional recovery (TKA: knee range of motion; THA: hip range of motion and gait; spinal fusion: ODI score);Early mobility (time to first ambulation, walking time, cumulative activity duration);QoR-15 score and patient satisfaction;Length of hospital stay;Cost of managing analgesia-related adverse reactions;

Countries

China

Contacts

Public ContactZhou Longyuan

Ningbo Medical Center Lihuili Hospital

396919647@qq.com+86 158 6721 2308

Outcome results

None listed

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