Actively Recruiting
A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2026-02-13
405
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center, randomized, double-blind, placebo/active-controlled study. 405 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK21542 group, morphine group, and placebo group.
CONDITIONS
Official Title
A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 74 years, any gender
- Body mass index (BMI) between 18 and 32 kg/m2
- American Society of Anesthesiologists (ASA) health status grade I to III
- Scheduled for hip replacement surgery under general anesthesia
- Numeric rating scale (NRS) pain score of 4 or higher at rest within 4 hours after surgery
- Able to understand and voluntarily consent to participate in the trial
You will not qualify if you...
- Allergy to opioids or any component of the trial drug
- History of severe cardiovascular, cerebrovascular, or psychiatric disorders
- Recent use of opioid or non-opioid analgesics within 5 half-lives or unclear half-life drugs affecting pain control within 7 days prior to randomization
- Continuous opioid use for more than 7 days in the 30 days before screening
- Abnormal laboratory test results including hematology, prothrombin time, liver/kidney function, or fasting blood glucose
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- History of drug or alcohol abuse
- Participation in another clinical trial within 30 days
- Pregnant or breastfeeding females
- Females of childbearing potential unwilling to use contraception or planning pregnancy within 3 months after the study
- Any other condition deemed by the investigator as ineligible for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
2
Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
Research Team
J
Jianwei Tang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here