A Phase Ⅱ Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Single Injection Intercostal Nerve Block With HR18034 for Postoperative Pain Management

HR18034-203

Phase Ⅱ, randomized, double-blind, comparator-controlled study to evaluate the efficacy, safety and pharmacokinetics of single injection intercostal nerve block with HR18034 for postoperative pain management compared with ropivacaine.

2023-02-21

2023-06-30

2023-06-30

Recruiting

Early phase I

96

Inclusion Criteria: 1. Able and willing to provide a written informed consent 2. Scheduled to undergo thoracoscopic lobectomy under general anesthesia. 3. Male or female, aged 18 years and older inclusive 4. Body mass index (BMI) 18-30 kg/m2 inclusive 5. American Society of Anesthesiologists (ASA) Physical Status Classification Ⅰ\~Ⅱ Exclusion Criteria: 1. Subjects with a history of new myocardial infarction or unstable angina within 6 months prior to randomization; 2. Subjects with a history of ischemic stroke or transient ischemic attack (TIA) 3. Subjects with a history of mental system diseases and cognitive dysfunction 4. Combination of other pain conditions that may affect postoperative pain assessment 5. Combination with ventilation disorders caused by airway or spinal anatomical factors, bronchiectasis, and severe chest adhesions on the surgical side 6. Clinically significant abnormal clinical laboratory test value 7. Allergic to a drug ingredient or component 8. Use of any of medications, which affect drug metabolism or analgesia evaluation, within 5 half-lives or as specified prior to the study surgical procedure 9. History of alcohol abuse or prescription and/or illicit drug abuse 10. Subjects with special diets (including tobacco, grapefruit and caffeine) 11. Pregnant or nursing women 12. No birth control during the specified period of time 13. Participated in clinical trials of other drugs (received experimental drugs) 14. The inestigators determined that other conditions were inappropriate for participation in this clinical trial

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'HR18034 compared with active comparator', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 96, 'type': 'ESTIMATED'}}

2023-03-15