Application of Tegileridine Fumarate Injection in Postoperative Analgesic Management of Posterior Lumbar Decompression, Bone Graft Fusion and Internal Fixation Surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500109437

Enrollment

Unknown

Registered

2025-09-18

Start date

2025-10-01

Completion date

Unknown

Last updated

2025-09-22

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

Conditions

Postoperative Analgesia

Interventions

Morphine group:Postoperative Analgesia with Morphine

Tegileridine group:Postoperative Analgesia with Tegileridine

Eligibility

Sex/Gender

All

Age

18 Years to 79 Years

Inclusion criteria

Inclusion criteria: Patients must meet all of the following inclusion criteria to be enrolled in this study: 1. Age greater than or equal to 18 years old and less than 80 years old; 2. American Society of Anesthesiologists (ASA) grade I.~III 3. Elective lumbar posterior decompression bone graft fusion internal fixation (1-2 segments); 4. Agree to use self-controlled intravenous analgesia after surgery; 5. Patients and their families understand this study, voluntarily participate in this trial, and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: Patients with any of the following cannot be enrolled in this study: 1. Body mass index (BMI) > 35 kg/m² or =30 days); 7. Use of oral or injectable glucocorticoids within three months before surgery; 8. Severe cardiovascular system disease (acute heart failure, unstable angina, myocardial infarction occurring within 6 months before screening, resting electrocardiogram (ECG) heart rate =450 ms, female >=470 ms); 9. Posterior lumbar decompression bone graft fusion internal fixation has been performed in the past, and this time it is a revision surgery.

Design outcomes

Primary

Measure	Time frame
Total Opioid Consumption Within 48 Hours Postoperatively;	—

Secondary

Measure	Time frame
Total Opioid Consumption Within 24 Hours Postoperatively;Total Presses and Effective Presses of the Analgesic Pump Within 24 Hours Postoperatively;Total Presses and Effective Presses of the Analgesic Pump Within 48 Hours Postoperatively;Maximum Resting Pain Score and Maximum Activity-Related Pain Score Within 24 Hours Postoperatively;Maximum Resting Pain Score and Maximum Activity-Related Pain Score Within 48 Hours Postoperatively;Patients' Satisfaction with Analgesic Pump Use;QoR-15 Score at Discharge;	—

Measure

Time frame

Total Opioid Consumption Within 24 Hours Postoperatively;Total Presses and Effective Presses of the Analgesic Pump Within 24 Hours Postoperatively;Total Presses and Effective Presses of the Analgesic Pump Within 48 Hours Postoperatively;Maximum Resting Pain Score and Maximum Activity-Related Pain Score Within 24 Hours Postoperatively;Maximum Resting Pain Score and Maximum Activity-Related Pain Score Within 48 Hours Postoperatively;Patients' Satisfaction with Analgesic Pump Use;QoR-15 Score at Discharge;

—

Countries

China

Contacts

Public ContactHua Zhen

Beijing Hospital

Hua1013@163.com+86 85136401

Outcome results

None listed

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