Total Knee Arthroplasty
Conditions
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.
Interventions
DRUGHR18034;Ropivacaine Hydrochloride Injection
Drug: HR18034 Drug: Ropivacaine Hydrochloride Injection Local nerve block of Ropivacaine Hydrochloride Injection to produce anesthesia for surgery and analgesia in postoperative pain management. Other Name: Ropivacaine Hydrochloride Injection, 0.5% Injectable Solution
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
HR18034 compared with active comparator
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Able and willing to provide a written informed consent 2. Scheduled to undergo primary unilateral total knee arthroplasty under general anesthesia. 3. Male or female，aged 18-75 years inclusive 4. Body mass index (BMI) 18-28 kg/m2 inclusive 5. American Society of Anesthesiologists (ASA) Physical Status Classification Ⅰ\ Ⅱ
Exclusion criteria
1. Subjects with deformity of the involving operative limb, or other neuropathy 2. Subjects with a history of new myocardial infarction or unstable angina within 6 months prior to randomization; 3. Subjects with a history of ischemic stroke or transient ischemic attack (TIA) 4. Subjects with a history of mental system diseases and cognitive dysfunction 5. Combination of other pain conditions that may affect postoperative pain assessment 6. Persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer 7. Subjects with a history of deep vein thrombosis-related disease 8. Clinically significant abnormal clinical laboratory test value 9. Allergic to a drug ingredient or component 10. 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 11. History of alcohol abuse or prescription and/or illicit drug abuse 12. Subjects with special diets (including tobacco, grapefruit and caffeine) 13. Pregnant or nursing women 14. No birth control during the specified period of time 15. Participated in clinical trials of other drugs (received experimental drugs) 16. The inestigators determined that other conditions were inappropriate for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-72 of the NRS-R pain intensity scores. | 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
| Measure | Time frame | Description |
|---|---|---|
| AUC of the NRS-A pain intensity scores. | 0-24, 0-48, 0-72 hours | AUC of NRS pain intensity scores at activity (NRS-A) for time periods 0-24, 0-48, 0-72 hours. |
| Pain intensity assessed using an 11-point NRS ranging. | Baseline till 72 hours after the beginning of study drug administration | 11-point Numercal Rating Scale ranging from a score of 0 to 10. Pain-free defined as an NRS of 0 or 1. Worst imaginable pain defined as an NRS of 10 |
| Proportion of subjects who used no rescue opioid analgesic. | 0-24, 24-48, 48-72, 0-72 hours | 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. |
| Total rescue analgesic consumption. | 0-24, 24-48, 48-72, 0-72 hours | Total rescue analgesic consumption through 0-24, 24-48, 48-72 and 0-72 hours after the beginning of study drug administration. |
| AUC of the NRS-R pain intensity scores. | 0-24, 0-48 hours | AUC of NRS pain intensity scores at rest (NRS-R) for time periods 0-24, 0-48 hours. |
| Quadriceps muscle strength score. | Baseline till 72 hours after the beginning of study drug administration | Quadriceps muscle strength score at 6, 8, 12, 16, 20, 24, 36, 48 and 72 hours. |
| Subjects' satisfaction rating | 72 hours | Subjects' satisfaction rating with postsurgical pain control at 72 hours. |
| Investigators' satisfaction rating | 72 hours | Investigators' satisfaction rating with postsurgical pain control at 72 hours. |
| Time to the first postoperative use of rescue opioid analgesics. | 0-72hours | Time to the first postoperative use of rescue opioid analgesics 0-72 hours after the beginning of study drug administration. |
Countries
China
Outcome results
None listed