---
title: A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery
nct_id: NCT07186426
overall_status: RECRUITING
phase: PHASE3
sponsor: Haisco Pharmaceutical Group Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Postoperative Pain Management
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07186426.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07186426"
ct_last_update_post_date: 2026-02-13
last_seen_at: "2026-05-12T06:45:28.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery

**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

**NCT ID:** [NCT07186426](https://clinicaltrials.gov/study/NCT07186426)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 405
- **Lead Sponsor:** Haisco Pharmaceutical Group Co., Ltd.
- **Conditions:** Postoperative Pain Management
- **Start Date:** 2025-07-28
- **Completion Date:** 2026-03-01
- **CT.gov Last Update:** 2026-02-13

## Brief 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

- **Minimum age:** 18 Years
- **Maximum age:** 74 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **HSK21542** (EXPERIMENTAL) — Patients administrated with HSK21542
- **Placebo control** (PLACEBO_COMPARATOR) — Patients administrated with placebo
- **Actice control** (ACTIVE_COMPARATOR) — Patients administrated with morphine

## Interventions

- **HSK21542** (DRUG) — Patients administrated with HSK21542
- **Placebo** (DRUG) — Patients administrated with placebo
- **morphine** (DRUG) — Patients administrated with morphine

## Primary Outcomes

- **Sum of Pain Intensity Differences (SPID)** _(time frame: 48 hours)_ — Sum of Pain Intensity Differences (SPID) of each group

## Secondary Outcomes

- **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)_

## Locations (2)

- Xuanwu Hospital Capital Medical University, Beijing, Beijing Municipality, China — _RECRUITING_
- Xiangya Hospital of Central South University, Changsha, Hunan, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.xuanwu hospital capital medical university|beijing|beijing municipality|china` — added _(2026-05-12)_
- `locations.xiangya hospital of central south university|changsha|hunan|china` — added _(2026-05-12)_

---

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