NCT07353996 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
| NCT ID | NCT07353996 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-10-25 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 180 participants in total. It began in 2025-10-25 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to determine the 90% effective dose (ED90) of a single intravenous injection of tegileridine fumarate for postoperative analgesia in adult patients aged 18-75 years with American Society of Anesthesiologists (ASA) physical status I-III undergoing orthopedic surgery, including spinal fusion surgery, femoral fracture fixation, and total knee arthroplasty. The main questions this study aims to answer are: What is the ED90 of a single intravenous dose of tegileridine fumarate for achieving adequate postoperative analgesia, defined as a Numeric Rating Scale (NRS) pain score ≤ 3 within 30 minutes after awakening from anesthesia without the need for rescue analgesia? Participants will: Receive a single intravenous injection of tegileridine fumarate during skin closure at the end of surgery. Start with an initial dose of 0.5 mg, with subsequent doses adjusted upward or downward in 0.1 mg increments for the next participant based on the analgesic response of the preceding participant, following a biased-coin up-and-down sequential dose allocation design. Be closely monitored during the postoperative recovery period for pain intensity, vital signs (including heart rate, blood pressure, respiratory rate, and oxygen saturation), and adverse reactions such as nausea, vomiting, respiratory depression, agitation, and other opioid-related side effects. This study aims to identify an optimal single-dose regimen of tegileridine fumarate that provides effective postoperative analgesia with an acceptable safety profile, thereby improving postoperative pain control and promoting enhanced recovery in patients undergoing orthopedic surgery.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07353996 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07353996 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07353996 currently recruiting?
Yes, NCT07353996 is actively recruiting participants. Contact the research team at zryanmin@zju.edu.cn for enrollment information.
Where is the NCT07353996 trial being conducted?
This trial is being conducted at Hanzhong, China.
Who is sponsoring the NCT07353996 clinical trial?
NCT07353996 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 180 participants.