Phase Ⅱ Study of Intercostal Nerve Block With HR18034 for Postsurgical Pain Management

Study Overview
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Brief Summary
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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.

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

Conditions
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Thoracoscopic Lobectomy

Intervention / Treatment
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* Drug: HR18034
* Drug: Ropivacaine Hydrochloride Injection


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: HR18034 compared with active comparator
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HR18034<br> | Drug: HR18034<br>* HR18034 228mg/342mg/456mg<br>|
| Active Comparator: Ropivacaine Hydrochloride Injection<br> | Drug: Ropivacaine Hydrochloride Injection<br>* Ropivacaine Hydrochloride Injection 60mg/90mg/120mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-72 of the NRS-A (or cough) pain intensity scores. | AUC of NRS pain intensity scores at activity (NRS-A) through 72 hours after the beginning of study drug administration. | 0 to 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of the NRS-A (or cough) pain intensity scores. | AUC of NRS pain intensity scores at activity (NRS-A) or cough for time periods 0-12, 12-24, 12-48, 12-72 hours. | 0-12, 12-24,12-48, 12-72 hours | 
| AUC of the NRS-R pain intensity scores. | AUC of NRS pain intensity scores at rest (NRS-R) for time periods 0-12, 12-24,12-48, 12-72, 0-72 hours. | 0-12, 12-24,12-48, 12-72, 0-72 hours | 
| Proportion of subjects who used no rescue opioid analgesic. | Proportion of subjects who used no rescue opioid analgesic through 0-24, 24-48, 48-72 and 0-72 hours after the beginning of study drug administration. | 0-24, 24-48, 48-72, 0-72 hours | 
| Total rescue analgesic consumption. | Total rescue analgesic consumption through 0-24, 24-48, 48-72 and 0-72 hours after the beginning of study drug administration. | 0-24, 24-48, 48-72, 0-72 hours | 
| Time to the first postoperative use of rescue opioid analgesics. | Time to the first postoperative use of rescue opioid analgesics 0-72 hours after the beginning of study drug administration. | 0-72 hours | 
| Subjects' satisfaction rating | Subjects' satisfaction rating with postsurgical pain control at 72 hours. | 72 hours | 
| Investigators' satisfaction rating | Investigators' satisfaction rating with postsurgical pain control at 72 hours. | 72 hours |