A Phase Ⅱ Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Single Injection Adductor Canal Block With HR18034 for Postoperative Pain Management
Overview
- Phase
- Phase 2
- Intervention
- HR18034;Ropivacaine Hydrochloride Injection
- Conditions
- Total Knee Arthroplasty
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Enrollment
- 89
- Locations
- 1
- Primary Endpoint
- AUC0-72 of the NRS-R pain intensity scores.
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
dose 1
Experimental: HR18034 190mg (10ml) Intervention: Drug: HR18034 Active Comparator: Ropivacaine Hydrochloride Injection Ropivacaine Hydrochloride Injection 50mg (10mL) Intervention: Drug: Ropivacaine Hydrochloride Injection
Intervention: HR18034;Ropivacaine Hydrochloride Injection
dose 2
Experimental: HR18034 285mg (15ml) Intervention: Drug: HR18034 Active Comparator: Ropivacaine Hydrochloride Injection Ropivacaine Hydrochloride Injection 75mg (15mL) Intervention: Drug: Ropivacaine Hydrochloride Injection
Intervention: HR18034;Ropivacaine Hydrochloride Injection
dose 3
Experimental:HR18034 380mg (20ml) Intervention: Drug: HR18034 Active Comparator: Ropivacaine Hydrochloride Injection Ropivacaine Hydrochloride Injection 100mg (20mL) Intervention: Drug: Ropivacaine Hydrochloride Injection
Intervention: HR18034;Ropivacaine Hydrochloride Injection
Outcomes
Primary Outcomes
AUC0-72 of the NRS-R pain intensity scores.
Time Frame: 0 to 72 hours
AUC of NRS pain intensity scores at rest (NRS-R) through 72 hours after the beginning of study drug administration.
Secondary Outcomes
- 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)