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

NCT07353996 | Recruiting Phase 4

• 1 other identifier: 2025-0393
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Effective dose producing adequate postoperative analgesia in 90% of patients (ED90)

  The primary outcome was the 90% effective dose (ED90) of a single intravenous bolus of tegileridine for postoperative analgesia following orthopedic surgery. Analgesic success was defined as a Numeric Rating Scale (NRS) pain score ≤ 3 within 30 minutes after awakening from anesthesia without the need for rescue analgesics. Dose allocation followed a biased-coin up-and-down sequential design, with dose adjustments based on the analgesic response of the preceding patient. The ED90 and its 90% confidence interval were estimated using isotonic regression analysis.

  Within 30 minutes after awakening from anesthesia

Secondary Outcomes (9)

• Incidence and severity of postoperative nausea and vomiting (PONV)

  From drug administration to 24 hours postoperatively

• Heart rate (HR)

  From immediately before drug administration to 24 hours postoperatively

• Respiratory Rate (RR)

  From immediately before drug administration to 24 hours postoperatively

• Peripheral Oxygen Saturation (SpO₂)

  From immediately before drug administration to 24 hours postoperatively

• Extubation-related airway responses

  From extubation until 10 minutes after extubation

Study Arms (1)

Single intravenous Tegileridine Fumarate arm

EXPERIMENTAL

Drug: Single intravenous injection of Tegileridine Fumarate

Interventions

Single intravenous injection of Tegileridine Fumarate DRUG

Single intravenous injection of tegileridine fumarate for postoperative analgesia in adult patients (18-75 years, ASA I-III) undergoing orthopedic surgery, including spinal fusion, femoral fracture fixation, and total knee arthroplasty. The study uses a dose-escalation design to determine the 90% effective dose (ED90). Doses: To be determined using an up-and-down sequential allocation method (dose-ranging study).

Single intravenous Tegileridine Fumarate arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hanzhong, Zhejiang, 3100000, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Min Yin Study Coordinator, Doctor

CONTACT

15888210247; zryanmin@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 21, 2026
• Study Start: October 25, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)