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Postoperative AnalgesiaPhase 3NCT04738357

A Clinical Study to Evaluate Efficacy and Safety of HSK21542 for Postoperative Analgesia of Subjects Undergoing Elective Laparoscopic Surgery Under General Anesthesia

A Phase 3 study testing HSK21542 in people with Postoperative Analgesia, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a multi-center, randomized, double-blind, placebo-controlled study. A total of 276 subjects undergoing elective laparoscopic surgery under general anesthesia are planned to be enrolled and randomized into 2 groups, i.e., the HSK21542 group (138 subjects) and the placebo group (138 subjects). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Postoperative Analgesia
What is being tested?
HSK21542
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
276 participants
Where
1 siteChina
Study dates
24 Mar 2021to 30 Sep 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 ≤ age ≤ 70 years old, with no gender requirement;
  • American Society of Anesthesiologists (ASA) Class I-II;
  • BMI ≥ 18 kg/m2 and ≤ 40 kg/m2;
  • Subjects undergoing elective laparoscopic surgery under general anesthesia with an expected surgery duration of 1-5 h (inclusive);
  • Agree to participate in this trial and voluntarily sign the informed consent form;

Who cannot join

  • With a history of allergy to opioids, such as urticaria, or allergic to intraoperative anesthetics as prescribed in the protocol;
  • Patients with history or evidence of any of the following diseases prior to screening:
  • History of cardiovascular diseases: uncontrolled hypertension (systolic blood pressure [SBP] ≥ 170 mmHg and/or diastolic blood pressure [DBP] ≥ 105 mmHg without treatment, or SBP > 160 mmHg and/or DBP > 100 mmHg despite antihypertensive treatment), aneurysm, severe arrhythmia, heart failure, Adams-stokes syndrome, New York Heart Association (NYHA) Class ≥ III, severe superior vena cava syndrome, pericardial effusion, acute myocardial ischemia, unstable angina, myocardial infarction within 6 months before screening, history of tachycardia/bradycardia requiring medical treatment, II-III degree atrioventricular block (excluding patients with pacemakers);
  • History of respiratory system disorders: severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe airway stenosis, throat mass, history of tracheoesophageal fistula or airway tear, severe respiratory infection within 2 weeks prior to screening;
  • History of neurological and psychiatric disorders: craniocerebral injury, convulsions, intracranial hypertension, cerebral aneurysms, history of cerebrovascular accidents; schizophrenia, mania, insanity, long-term use of psychotropic drugs, and history of cognitive dysfunction; history of depression, anxiety, and epilepsy, etc.;
  • Have undergone any major surgery within 3 months prior to screening, which may affect postoperative pain assessment as judged by the investigator;
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  • In receipt of any one of the following medications or treatments at screening:
  • A time between the last use of opioid and non-opioid (such as paracetamol, aspirin [daily dose > 100 mg], indometacin, diclofenac, parecoxib sodium, and other non-steroidal anti-inflammatory drugs) analgesics and randomization of shorter than 5 half-lives of the drug or the duration of response (whichever is longer);
  • Longer than 10 days of continuous use of opioid analgesics for any reason within 3 months prior to screening;
  • Use of drugs with unknown half-life that affect the analgesic effect within 14 days before randomization, or the last use of drugs that affect the analgesic effect is within 5 half-lives (as per the packaging insert of the drug) apart from randomization, such drugs include but are not limited to: sedative-hypnotics (benzodiazepines [triazolam, diazepam, midazolam, etc.], non-benzodiazepines [zolpidem, zopiclone, zaleplon, etc.]), sedative anesthetics (sevoflurane, anesthetic ether, nitrous oxide, thiopental sodium, ketamine, etomidate, etc.), glucocorticoids (dexamethasone hydrochloride, methylprednisolone, etc.), antiepileptics (carbamazepine, sodium valproate, etc.), anxiolytics (chlordiazepoxide, diazepam, etc.), antidepressants (imipramine, amitriptyline, etc.), and Chinese herbal medicines or Chinese patent medicines with analgesic and sedative effects;
  • Expected to receive any anti-tumor drug or therapy from 14 days prior to randomization to the end of the follow-up period, including but not limited to chemotherapy drugs, targeted drugs, and Chinese herbal medicines;
  • A time between randomization and the last use of diuretics and compound drugs containing diuretics of shorter than 5 half-lives of the drug or the duration of response (whichever is longer);
  • The laboratory parameters measured at screening period reach one of the following criteria:
  • WBC < 3.0 × 109/L;
  • Platelet count < 80 × 109/L;
  • Hemoglobin < 70 g/L;
  • Prothrombin time > 1.5 × ULN;
  • Activated partial thromboplastin time > 1.5 × ULN;
  • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 × ULN;
  • Total bilirubin > 1.5 × ULN;
  • Blood creatinine > 1.5 × ULN;
  • Fasting blood glucose ≥ 11.1 mmol/L;
  • Positive for hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody at screening;
  • History of medication or drug abuse and/or alcohol abuse within 3 months prior to screening (alcohol abuse is defined as an average of > 2 units of alcohol consumed per day [1 unit = 360 mL of beer with 5% alcohol, 45 mL of liquor with 40% alcohol, or 150 mL of wine]);
  • History of blood donation or blood loss of ≥ 400 mL within 3 months prior to screening;
  • Have participated in other clinical trials within 3 months prior to screening (defined as having received investigational product or placebo);
  • Pregnant or breastfeeding females; women of child-bearing potential or men who are unwilling to use contraception during the trial; or subjects who are planning pregnancy within 3 months after the completion of the trial (including male subjects);
  • Subject judged by the investigator to have any other factors unsuitable for involvement in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou

Other trials in China

About this study

Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HSK21542 Injection for Postoperative Analgesia of Subjects Undergoing Elective Laparoscopic Surgery Under General Anesthesia

This study is a multi-center, randomized, double-blind, placebo-controlled study. A total of 276 subjects undergoing elective laparoscopic surgery under general anesthesia are planned to be enrolled and randomized into 2 groups, i.e., the HSK21542 group (138 subjects) and the placebo group (138 subjects).

Being tested
HSK21542, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HSK21542Drug

    HSK21542：1 µg/kg

  • PlaceboDrug

    Placebo

Study groups in NCT04738357
Study groupRoleWhat they receive
HSK21542ExperimentalNot described
Receives: Drug: HSK21542
placeboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sum of Pain Intensity Differences (SPID)

    The time-weighted SPID at rest within 0-24 h after the first postoperative administration in each group

    Measured: Frome administration until 24 hours after administration

Secondary outcomes (8)

  1. Sum of Pain Intensity Differences (SPID)

    The time-weighted SPID at rest within 0-12 h after the first postoperative administration in each group

    Measured: Frome administration until 12 hours after administration

  2. Use of remedial analgesics

    Cumulative used amount of remedial analgesics (morphine injection, mg) within 0-12 h or 0-24 h after the first postoperative administration in each group, percentage of subjects not using remedial analgesics, and start time of remedial analgesic use

    Measured: Frome administration until 24 hours after administration

  3. Pain Intensity Differences（PID）

    The PID at rest at each scoring time point after the first postoperative administration in each group

    Measured: Frome administration until 24 hours after administration

  4. The proportion of subjects with a NRS of ≤ 3

    The ratio of subjects with NRS score ≤ 3 at 12 h or 24 h after the first postoperative administration in each group

    Measured: Frome administration until 24 hours after administration

  5. Duration of analgesia

    The duration of analgesia after the first postoperative administration in each group

    Measured: Frome administration until 24 hours after administration

  6. Satisfaction scores on postoperative analgesia

    Subject satisfaction score and investigator satisfaction score on postoperative analgesia at 24 h after the first postoperative administration in each group

    Measured: Frome administration until 24 hours after administration

  7. The incidence and severity of AEs

    Adverse event/serious adverse event

    Measured: from signing the informed consent form to the follow-up period (D8 ± 1 postoperative).

  8. Cumulative used amount and ratio of antiemetics

    Cumulative used amount and ratio of antiemetics within 0-24 h after the first postoperative administration in each group

    Measured: Frome administration until 24 hours after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2021
  2. Study start24 Mar 2021
  3. Primary completion30 Jul 2021
  4. Study completion30 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04738357
Sponsor's protocol ID
HSK21542-301
Status last verified
May 2022
First submitted
31 Jan 2021
Last updated
21 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yu S, Zou L, Dong S, Wu J, Huang X, Zhong Y, Wang H, Yao Y, Yan M. HSK21542 for Postoperative Analgesia in Gynecological Surgery: A Pooled Post-Hoc Analysis of Two Phase III Randomized Controlled Trials. Anesth Analg. 2026 Oct 1;143(4):869-876. doi: 10.1213/ANE.0000000000008004. Epub 2026 Mar 23.

    PubMed 41874970

  • Zhong Y, Xu Y, Lei Q, Yang M, Wang S, Hu X, Xie H, Li Y, Qin Z, Gu Z, Zhang J, Wang Y, Wu J, Wang H, Ming Y, Xia Z, Zhai H, Jiang K, Zhang P, Wang Z, Wang L, Li L, Cheng Z, Jiang H, Wang G, Chen J, Zhao Z, Chen X, Yan M. HSK21542 in patients with postoperative pain: two phase 3, multicentre, double-blind, randomized, controlled trials. Nat Commun. 2025 May 24;16(1):4830. doi: 10.1038/s41467-025-60013-y.

    PubMed 40413233

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HSK21542 in people with Postoperative Analgesia, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sum of Pain Intensity Differences (SPID) (time frame: Frome administration until 24 hours after administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04738357, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.

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