A Phase Ⅱ Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Single Injection Adductor Canal Block With HR18034 for Postoperative Pain Management
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- AUC0-72 of the NRS-R pain intensity scores.
研究概览
简要总结
Phase Ⅱ, randomized, double-blind, comparator-controlled study to evaluate the efficacy, safety and pharmacokinetics of single injection adductor canal block with HR18034 for postoperative pain management compared with ropivacaine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide a written informed consent
- •Scheduled to undergo primary unilateral total knee arthroplasty under general anesthesia.
- •Male or female，aged 18-75 years inclusive
- •Body mass index (BMI) 18-28 kg/m2 inclusive
- •American Society of Anesthesiologists (ASA) Physical Status Classification Ⅰ~Ⅱ
排除标准
- •Subjects with deformity of the involving operative limb, or other neuropathy
- •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
- •Persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer
- •Subjects with a history of deep vein thrombosis-related disease
- •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
研究组 & 干预措施
dose 1
Experimental: HR18034 190mg (10ml)
Intervention: Drug: HR18034
Active Comparator: Ropivacaine Hydrochloride Injection
Ropivacaine Hydrochloride Injection 50mg (10mL)
Intervention: Drug: Ropivacaine Hydrochloride Injection
干预措施: HR18034;Ropivacaine Hydrochloride Injection (Drug)
dose 2
Experimental: HR18034 285mg (15ml)
Intervention: Drug: HR18034
Active Comparator: Ropivacaine Hydrochloride Injection
Ropivacaine Hydrochloride Injection 75mg (15mL)
Intervention: Drug: Ropivacaine Hydrochloride Injection
干预措施: HR18034;Ropivacaine Hydrochloride Injection (Drug)
dose 3
Experimental:HR18034 380mg (20ml)
Intervention: Drug: HR18034
Active Comparator: Ropivacaine Hydrochloride Injection
Ropivacaine Hydrochloride Injection 100mg (20mL)
Intervention: Drug: Ropivacaine Hydrochloride Injection
干预措施: HR18034;Ropivacaine Hydrochloride Injection (Drug)
结局指标
主要结局
AUC0-72 of the NRS-R pain intensity scores.
时间窗: 0 to 72 hours
AUC of NRS pain intensity scores at rest (NRS-R) through 72 hours after the beginning of study drug administration.
次要结局
- Time to the first postoperative use of rescue opioid analgesics.(0-72hours)
- Subjects' satisfaction rating(72 hours)
- Pain intensity assessed using an 11-point NRS ranging.(Baseline till 72 hours after the beginning of study drug administration)
- Proportion of subjects who used no rescue opioid analgesic.(0-24, 24-48, 48-72, 0-72 hours)
- Total rescue analgesic consumption.(0-24, 24-48, 48-72, 0-72 hours)
- AUC of the NRS-R pain intensity scores.(0-24, 0-48 hours)
- AUC of the NRS-A pain intensity scores.(0-24, 0-48, 0-72 hours)
- Quadriceps muscle strength score.(Baseline till 72 hours after the beginning of study drug administration)
- Investigators' satisfaction rating(72 hours)