A Multicentre, Randomised, Double-blind, Positive-drug-controlled Phase III Clinical Trial on the Efficacy and Safety of CZ1S Peroneal Nerve Block Combined With Popliteal Artery and Posterior Capsule Gap Block for Postoperative Analgesia in Total Knee Arthroplasty.

NCT07812558 | Completed Phase 3

• 1 other identifier: ZJCZ-CZ1S-051
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicentre, randomised, double-blind, positive-drug-controlled confirmatory clinical trial designed to evaluate the efficacy and safety of CZ1S injection for femoral nerve block (FNB) combined with the interspace between the popliteal artery and the capsule of the knee (IPACK) block for postoperative analgesia following total knee arthroplasty (TKA).

Conditions

Femoral Nerve Block (FNB); Interspace Between the Popliteal Artery and the Capsule of the Knee (IPACK); Total Knee Arthroplasty (TKA)

Outcome Measures

Primary Outcomes (1)

• Pain intensity is assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate a worse outcome.

  72 hours

Study Arms (2)

Ropivacaine injection

ACTIVE COMPARATOR

Ropivacaine injection

Drug: ropivacaine (local infiltration)

CZ1S for injection

EXPERIMENTAL

CZ1S for injection

Drug: CZ1S for Injection

Interventions

ropivacaine (local infiltration) DRUG

positive drug

Ropivacaine injection

CZ1S for Injection DRUG

investigational product

CZ1S for injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Subjects with pain unrelated to the indications for total knee arthroplasty, which the investigator judges may confound postoperative assessment (e.g., pain caused by lumbar nerve disease).
• Subjects planning to undergo surgery on other sites simultaneously.
• Subjects with a history of any of the following serious clinical diseases or currently suffering from serious diseases:
• Respiratory diseases: such as acute or bronchial asthma, pulmonary heart disease, other chronic lung diseases, or a history of respiratory depression;
• Circulatory system diseases: such as unstable angina and/or myocardial infarction within the past 6 months, patients with heart failure (New York Heart Association \[NYHA\] Class III-IV), atrial fibrillation, ventricular fibrillation, prolonged QTcF interval (12-lead ECG examination): males ≥450ms, females ≥470ms (if initially abnormal, may retest three times and take the average); poorly controlled hypertension (resting seated systolic blood pressure ≥160mmHg for two or more consecutive readings, or diastolic blood pressure ≥100mmHg);
• Blood system diseases: bleeding disorders caused by clotting factor deficiencies or other coagulation abnormalities;
• Tumours: history of malignant tumour within the past year, except for non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin or local cervical carcinoma in situ;
• Digestive system diseases: known gastrointestinal bleeding, gastrointestinal obstruction or perforation, or other diseases that may pose a risk to the gastrointestinal tract; f) Presence of other diseases that may significantly affect the evaluation of the investigational drug efficacy or metabolism in the body.
• Diagnosed progressive femoral nerve dysfunction or chronic neuromuscular injury.
• Subjects experiencing vomiting during the screening period or with a history of severe, refractory postoperative nausea and vomiting.
• Subjects with screening laboratory results meeting the following criteria: a) Liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 times the upper limit of normal (ULN) or total bilirubin (TBIL) ≥1.5×ULN; b) Renal function: serum creatinine (Cr) ≥1.5×ULN; c) Coagulation function: prothrombin time (PT) \>3s above the upper limit of normal and/or activated partial thromboplastin time (APTT) \>10s above the upper limit of normal; d) Random blood glucose ≥11.1mmol/L.
• Individuals allergic to any component of the investigational medicinal product, general anaesthesia regimen drugs, rescue analgesics, or antiemetic medications, or with other contraindications.
• Use or anticipated use of opioids, NSAIDs, sedatives, anaesthetics, local anaesthetics, glucocorticoids, antiepileptics, anxiolytics, antidepressants, traditional Chinese medicines with analgesic effects, class III antiarrhythmic drugs, potent CYP1A2 inhibitors, CYP1A2 highly sensitive substrates, potent CYP3A4 inhibitors, CYP3A4 highly sensitive substrates, potent CYP3A4 inducers within five half-lives before randomisation (based on the actual drug label; if half-life is unknown, washout period should be at least 48 hours), except as specified in the protocol. (See Appendix 1 for prohibited concomitant drugs/non-drug treatments)
• Regular alcohol consumption within the 3 months (90 days) prior to screening, defined as more than 14 units per week (1 unit = 360 mL of beer, or 45 mL of 40% spirit, or 150 mL of wine).
• Participation in a drug or device clinical trial within the 3 months (90 days) prior to screening, with use of investigational medicinal products or devices. Previous participation in clinical trials of this study drug or similar analgesics (including but not limited to Exparel ®, HYR-PB21, Aihengping®).

Sponsors & Collaborators

• Zhejiang Cuize Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

MeSH Terms

Interventions

Ropivacaine; Injections

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 10, 2026
• Study Start: July 3, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 10, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)