Finding the best single IV dose of tegileridine for pain after orthopedic surgery
Official title: 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
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT07353996 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Locations | 1 site (Hanzhong, Zhejiang) |
| Status | Recruiting |
| Started | October 25, 2025 |
| Main results expected | March 1, 2026 |
| Study ends | May 1, 2026 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT07353996 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.