HSK21542 for relieving pain after hip replacement

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

We are testing whether HSK21542, compared with morphine and placebo, reduces pain in adults 18–74 after hip replacement under general anesthesia.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 405 (estimated)
• Ages: 18 Years to 74 Years
• Sex: All
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. (industry)
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT07186426 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, placebo- and active-controlled Phase 3 study enrolling about 405 adults undergoing hip replacement under general anesthesia. Participants are randomized to receive HSK21542, morphine, or placebo and are evaluated for pain intensity within the first hours after surgery (required NRS≥4 within 4 hours postoperatively). The trial collects safety and efficacy data to compare pain relief and adverse events between the investigational drug, an opioid comparator, and placebo. Sites include academic hospitals in Beijing and Changsha and the protocol limits enrollment by age, BMI, ASA class, and recent analgesic use.

Who should consider this trial

Good fit: Adults aged 18–74 with BMI 18–32 kg/m2, ASA class I–III, undergoing hip replacement under general anesthesia who report moderate to severe resting pain (NRS≥4) within 4 hours after surgery are the intended participants.

Not a fit: Patients allergic to opioids or the study drug components, those with severe cardiovascular/cerebrovascular or psychiatric disorders, recent use of interfering analgesics, or who fall outside the age/BMI/ASA limits are unlikely to qualify or benefit from participation.

Why it matters

Potential benefit: If successful, HSK21542 could offer effective postoperative pain relief and potentially reduce reliance on or side effects from conventional opioids.

How similar studies have performed: Related non-morphine analgesics and early-phase trials of novel agents have shown mixed results, so Phase 3 data are needed to establish whether HSK21542 offers a clear advantage over standard opioids.

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.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Xuanwu Hospital Capital Medical University — Beijing, Beijing Municipality, China (RECRUITING)
• Xiangya Hospital of Central South University — Changsha, Hunan, China (RECRUITING)

Study contacts

• Study coordinator: Jianwei Tang

Conditions: Postoperative Pain Management