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

NCT07810413 | Not Yet Recruiting

• 1 other identifier: KY-20250709002-02
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Postoperative Pain

Keywords

Thoracic Surgery; Anrikefon; Sufentanil

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Difference over 24 Hours (SPID₂₄)

  0 to 24 hours after first dose

Secondary Outcomes (6)

• Number and Dose of Rescue Medication

  0 to 24 hours after first dose

• Incidence of Postoperative Nausea and Vomiting (PONV) at 24 Hours

  0 to 24 hours after first dose

• PCA Pump Demand (Total, Effective, and Delivered Dose)

  0 to 24 hours after first dose

• Time to First Rescue Medication

  0 to 24 hours after first dose

• Proportion of Subjects Requiring Rescue Medication

  0 to 24 hours after first dose

Study Arms (2)

Anrikefon (HSK21542) Group

EXPERIMENTAL

Drug: Anrikefon Injection

Sufentanil Group

ACTIVE COMPARATOR

Drug: Sufentanil Citrate Injection

Interventions

Anrikefon Injection DRUG

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.

Anrikefon (HSK21542) Group

Sufentanil Citrate Injection DRUG

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.

Sufentanil Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 85 years (inclusive), either sex.
• Body mass index (BMI) 18.0 to 30.0 kg/m² (inclusive).
• American Society of Anesthesiologists (ASA) physical status Class I to III preoperatively.
• 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.
• 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.
• Voluntarily participating and providing written informed consent.

You may not qualify if:

• Known or suspected allergy or contraindication to any of the study drugs.
• History of opioid abuse, drug or alcohol dependence, or current preoperative use of opioids.
• Use of analgesic medications (acetaminophen, NSAIDs, opioids, tramadol, etc.) within 24 hours preoperatively.
• 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.
• History of chronic pain.
• Severe respiratory or circulatory failure during anesthesia/surgery (including intraoperative conversion to thoracotomy, operative time \> 6 hours, or intraoperative hemorrhage \> 1000 mL).
• Pregnancy or lactation, or positive urine pregnancy test in women of childbearing potential.
• Participation in another drug/device clinical trial within 30 days before randomization.
• Any other condition that the investigator deems unsuitable for participation.

Sponsors & Collaborators

• The First People's Hospital of Lianyungang: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sufentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 9, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share