Anrikefon Injection for Postoperative Analgesia in Thoracoscopic Lung Surgery: A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Single-Center Clinical Study

September 3, 2026 updated by: The First People's Hospital of Lianyungang
This is a randomized, double-blind, active-controlled clinical study evaluating the efficacy and safety of Anrikefon (HSK21542) Injection for patient-controlled analgesia (PCA) in patients undergoing thoracoscopic lung surgery. Subjects aged 18-85 years with a postoperative resting NRS score ≥ 4 will be enrolled. Eligible participants will be randomized 1:1 to receive either Anrikefon (HSK21542) or sufentanil via PCA pump for 24 hours post-surgery. The primary endpoint is the 24-hour summed pain intensity difference (SPID₂₄). A total of 88 subjects are planned for enrollment. The study has received ethics committee approval.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 to 85 years (inclusive), either sex.
  2. Body mass index (BMI) 18.0 to 30.0 kg/m² (inclusive).
  3. American Society of Anesthesiologists (ASA) physical status Class I to III preoperatively.
  4. Undergoing elective thoracoscopic lung surgery under general anesthesia (complete video-assisted thoracoscopic surgery, without conversion to thoracotomy), with successful recovery from anesthesia within 1 hour postoperatively, fully awake, able to accurately complete NRS scoring with an NRS score ≥ 4, and willing to accept the analgesic regimen defined in the study protocol.
  5. Able to understand the purpose, procedures, and scale scoring methods of the study, capable of operating the PCA device, and able to communicate effectively with investigators.
  6. Voluntarily participating and providing written informed consent.

Exclusion Criteria:

  1. Known or suspected allergy or contraindication to any of the study drugs.
  2. History of opioid abuse, drug or alcohol dependence, or current preoperative use of opioids.
  3. Use of analgesic medications (acetaminophen, NSAIDs, opioids, tramadol, etc.) within 24 hours preoperatively.
  4. Uncontrolled severe cardiovascular disease (second-degree or higher atrioventricular block, resting heart rate < 50 bpm, uncontrolled hypertension, myocardial infarction or unstable angina within the past 6 months), hepatic insufficiency (ALT/AST > 2× upper limit of normal), renal insufficiency (eGFR < 30 mL/min/1.73m² or maintenance dialysis), neuropsychiatric dysfunction, or inability to cooperate with pain assessment.
  5. History of chronic pain.
  6. Severe respiratory or circulatory failure during anesthesia/surgery (including intraoperative conversion to thoracotomy, operative time > 6 hours, or intraoperative hemorrhage > 1000 mL).
  7. Pregnancy or lactation, or positive urine pregnancy test in women of childbearing potential.
  8. Participation in another drug/device clinical trial within 30 days before randomization.
  9. Any other condition that the investigator deems unsuitable for participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Anrikefon (HSK21542) Group
Drug: Anrikefon Injection
Active ingredient: Anrikefon. Specification: 1 mL: 0.1 mg. Dosage: diluted to working solution of 10 μg/mL in 100 mL; loading dose 1.0 μg/kg; PCA bolus 2 mL per demand; lockout interval 15 min.
Active Comparator: Sufentanil Group
Drug: Sufentanil Citrate Injection
Specification: 1 mL: 50 μg. Dosage: 2 μg/kg diluted to 100 mL solution; loading dose 0.1 μg/kg; PCA bolus 2 mL per demand; lockout interval 15 min.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Sum of Pain Intensity Difference over 24 Hours (SPID₂₄)
Time Frame: 0 to 24 hours after first dose
0 to 24 hours after first dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number and Dose of Rescue Medication
Time Frame: 0 to 24 hours after first dose
0 to 24 hours after first dose
Incidence of Postoperative Nausea and Vomiting (PONV) at 24 Hours
Time Frame: 0 to 24 hours after first dose
0 to 24 hours after first dose
PCA Pump Demand (Total, Effective, and Delivered Dose)
Time Frame: 0 to 24 hours after first dose
0 to 24 hours after first dose
Time to First Rescue Medication
Time Frame: 0 to 24 hours after first dose
0 to 24 hours after first dose
Proportion of Subjects Requiring Rescue Medication
Time Frame: 0 to 24 hours after first dose
0 to 24 hours after first dose
Treatment Failure Rate Due to Inadequate Analgesia
Time Frame: 0 to 24 hours after first dose
0 to 24 hours after first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First People's Hospital of Lianyungang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY-20250709002-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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