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Recruiting NCT07186426

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

Phase III Interventional Postoperative Pain Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HSK21542, Placebo, morphine.
Who it may be relevant to
Registry conditions: Postoperative Pain Management. Basic parameters: 18 years — 74 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug HSK21542
    Patients administrated with HSK21542
  • Drug Placebo
    Patients administrated with placebo
  • Drug morphine
    Patients administrated with morphine

Primary outcome measures

  • Sum of Pain Intensity Differences (SPID) [Time frame: 48 hours]
Secondary outcome measures (5)
  • Proportion of subjects experiencing nausea [Time frame: 48 hours]
  • Proportion of subjects experiencing vomit [Time frame: 48 hours]
  • Sum of Pain Intensity Differences (SPID) in other time frame [Time frame: 0-8 hours, 0-24 hours, 24-48 hours]
  • Number of times rescue analgesic medications were administered. [Time frame: 48 hours]
  • Total morphine consumption [Time frame: 48 hours]

Eligibility criteria

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.；
  • Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • Xuanwu Hospital Capital Medical University — Beijing
  • Xiangya Hospital of Central South University — Changsha

Identifiers

NCT: NCT07186426 · HSK21542-305

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗