drugset / Trial / NCT07810413
Anrikefon Injection for Postoperative Analgesia in Thoracoscopic Lung Surgery: A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Single-Center Clinical Study
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2026-09-30
- Primary completion
- 2026-12-31
- Completion
- 2027-05-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anrikefon | Unknown | 20 ug | — |
| Comparator | Sufentanil | Other / unclassified | 2 ug/kg | — |
Indications
No indication recorded.