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New treatment option for Postoperative Pain
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
ClinicalTrials.gov ID: NCT07353996
What this study is testing
What is Single intravenous injection of Tegileridine Fumarate?
Single intravenous injection of Tegileridine Fumarate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for postoperative pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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 likely can't join 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%).
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hanzhong, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hanzhong, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.