Finding the best single IV dose of tegileridine for pain after orthopedic surgery
Determination of the Effective Dose of a Single Intravenous Dose of Tegileridine Fumarate for Postoperative Analgesia After Orthopedic Surgery: A Up-and-Down Sequential Allocation Study
This test tries single IV doses of tegileridine in adults 18–75 having orthopedic surgery to see which dose gives good pain relief after surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hanzhong, Zhejiang) |
| Trial ID | NCT07353996 on ClinicalTrials.gov |
What this trial studies
This Phase 4, interventional up-and-down sequential allocation study gives a single IV injection of tegileridine fumarate at skin closure to adults undergoing elective orthopedic procedures. The initial dose is 0.5 mg and subsequent participants receive doses adjusted by 0.1 mg up or down based on the previous patient’s pain control. The primary endpoint is achieving a pain score of 3 or less on the Numeric Rating Scale within 30 minutes after waking without needing rescue analgesia. The goal is to determine the ED90—the dose effective in 90% of patients—for postoperative analgesia.
Who should consider this trial
Good fit: Adults aged 18–75 with ASA physical status I–III scheduled for elective spinal fusion, femoral fracture fixation, or total knee arthroplasty who can give informed consent and do not have BMI over 30 are ideal candidates.
Not a fit: Patients with BMI over 30, chronic opioid use or chronic pain, severe hepatic or renal impairment, need for postoperative ICU care, significant respiratory depression, or suspected gastrointestinal obstruction are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could identify an optimal single IV dose that improves early postoperative pain control while minimizing unnecessary dosing and side effects.
How similar studies have performed: Up-and-down dose-finding designs are commonly used and have successfully identified effective doses for other IV analgesics, but published ED90 data specific to tegileridine fumarate are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 to 75 years. * Scheduled for elective orthopedic surgery, including spinal fusion, femoral fracture fixation, or total knee arthroplasty. * American Society of Anesthesiologists (ASA) physical status I-III. * Ability to understand the study procedures and provide written informed consent. Exclusion Criteria: * Patients with moderate to severe obesity (BMI \> 30 kg/m²). * Known hypersensitivity or allergy to tegileridine fumarate or other analgesics. * History of chronic pain or long-term use of opioids. * Severe hepatic or renal impairment. * Patients requiring postoperative ICU care. * Severe respiratory depression (e.g., oxygen saturation \< 90%). * Known or suspected gastrointestinal obstruction, including paralytic ileus.
Where this trial is running
Hanzhong, Zhejiang
- The Second Affiliated Hospital of Zhejiang University anesthesiology department — Hanzhong, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Min Yin Study Coordinator, Doctor
- Email: zryanmin@zju.edu.cn
- Phone: 15888210247
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.