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A national multicenter, real-world study evaluating the safety and efficacy of tegileridine fumarate injection in the treatment of postoperative pain

A national multicenter, real-world study evaluating the safety and efficacy of tegileridine fumarate injection in the treatment of postoperative pain

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114535
Enrollment
Unknown
Registered
2025-12-15
Start date
2025-12-22
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Postoperation pain

Interventions

Observation group (taglidine):None

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old, gender not limited; 2. Scheduled for elective surgery, patients who experienced moderate to severe postoperative pain, with NRS score = 4 points; 3. Patients voluntarily signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. American Society of Anesthesiologists (ASA) physical condition classification of grade IV or above; 2. Patients with severe respiratory depression, such as those with oxygen saturation below 90%; 3. Patients with acute or severe bronchial asthma; 4. Patients with known or suspected gastrointestinal obstruction, including paralytic intestinal obstruction; 5. Patients allergic to any component of opioids and investigational drugs; 6. Pregnant or lactating women; 7. Patients deemed ineligible by the investigators.

Design outcomes

Primary

MeasureTime frame
The incidence rates of adverse events (AE) and serious adverse events (SAE);Subjective Opioid Withdrawal Scale (SOWS) score on the second day after the last administration;

Secondary

MeasureTime frame
Pain intensity scores measured in the resting state and during physical activity (or coughing) before administration, 5 minutes after administration, 30 minutes after administration, 6 hours after administration, and 24 hours after administration.;Pain relief scores at 5 minutes, 30 minutes, 6 hours, and 24 hours after administration;RASS sedation scores before administration and at 5 minutes, 30 minutes, 6 hours, and 24 hours after administration;Blood oxygen saturation before administration and at 5 minutes, 30 minutes;Incidence of opioid-related adverse events within 24 hours after the first administration;Exposure to the test drug;Information on concomitant medications,;

Countries

China

Contacts

Public ContactXiangdong Chen

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

xdchen@deit.ecnu.edu.cn+86 150 7109 6621

Outcome results

None listed

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