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A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery | Clinical Trials | Clareo Health

RECRUITINGPHASE3

A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery

A Multi-Center, Randomized, Double-Blind, Placebo/Active-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HSK21542 Injection for Postoperative Pain Treatment in Orthopedic Surgery

NCT07186426•Haisco Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 74 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•18 years old ≤ age ≤74 years old, regardless of gender;
•18 kg/m2≤BMI≤32 kg/m2，meet the weight range specified in the protocol；
•American Society of Anesthesiologists (ASA) grade ⅰ-ⅲ;
•Accept hip replacement under general anesthesia;
•Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time;
•Fully understand and voluntarily participate this trial, and sign the informed consent form;

Exclusion Criteria

•Patients with allergy to opioids or any component of the trial drug；
•Patients with a history of severe cardiovascular and cerebrovascular diseases, ,and psychiatric disorders;
•Last use of opioid or non-opioid analgesics less than 5 half-lives or the duration of drug efficacy prior to randomization; use of drugs with unclear half-lives that may affect analgesic efficacy within 7 days prior to randomization, or last use of drugs affecting analgesic efficacy less than 5 half-lives prior to randomization, as well as Chinese herbal medicines or proprietary Chinese medicines deemed by the investigator as potentially impacting the evaluation of efficacy and safety；
•Continuous use of opioid analgesics for more than 7 days for any reason within 30 days prior to screening;
•Laboratory test results during the screening period meeting any of the following criteria: 1) Significantly abnormal hematology results; 2) Significantly abnormal prothrombin time test results; 3) Significantly abnormal liver or kidney function; 4) Significantly abnormal fasting blood glucose;
•Positive test results during the screening period for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody;
•A history of drug, drug, and/or alcohol abuse；
•Participate in any clinical trail within 30 days;
•Pregnant or lactating female subjects；
•Subjects of childbearing potential who are unwilling to use contraception throughout the study period or plan to become pregnant within 3 months after the study.；
+1 more criteria

Locations (2)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

Key Dates

Start Date

July 28, 2025

Primary Completion Date

March 1, 2026

Completion Date

March 1, 2026

Last Updated

February 13, 2026

Enrollment

405

ESTIMATED participants

Conditions

Postoperative Pain Management

Interventions

HSK21542

DRUG

Placebo

DRUG

morphine

DRUG

Contacts

Jianwei Tang

CONTACT

028-67258779 tangjianw@haisco.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery

Inclusion Criteria

Exclusion Criteria

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