Anrikefon injection for postoperative analgesia in thoracoscopic lung surgery: a randomized, Double-Blind, Active-Controlled, Parallel-Group, Single-Center clinical study

NCT ID NCT07810413

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By invitation only
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
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First seen Sep 09, 2026 · Last updated Sep 09, 2026

Summary

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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 88 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Pain, Postoperative

As listed by the trial registrant

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