Postoperative Pain
Conditions
Keywords
Thoracic Surgery, Anrikefon, Sufentanil
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.
Interventions
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.
DRUGSufentanil 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.
Sponsors
The First People's Hospital of Lianyungang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sum of Pain Intensity Difference over 24 Hours (SPID₂₄) | 0 to 24 hours after first dose |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Treatment Failure Rate Due to Inadequate Analgesia | 0 to 24 hours after first dose |
Outcome results
None listed