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Sponsor's R&D Strategy adjusted
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Phase â…¡, 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 in total knee arthroplasty compared with ropivacaine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental |
| |
| Dose 2 | Experimental |
| |
| Ropivacaine Hydrochloride Injection | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR18034 | Drug | HR18034 |
| |
| Ropivacaine Hydrochloride Injection |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-72h of the NRS-A 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of the NRS-A pain intensity scores. | AUC of NRS pain intensity scores at activity (NRS-A) for time periods 0-24, 0-48 hours. | 0-24, 0-48hours |
| AUC of the NRS-R pain intensity scores. | 0-24, 0-48,0-72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Drug |
Ropivacaine Hydrochloride Injection |
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| AUC of NRS pain intensity scores at rest (NRS-R) for time periods 0-24, 0-48 ,0-72 hours. | 0-24, 0-48 ,0-72 hours. |
| Pain intensity assessed using an 12-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 |
| Time to the first postoperative use of rescue opioid analgesics. | 0-72hours |
| Quadriceps muscle strength score. | Baseline till 72 hours after the beginning of study drug administration |
| Range of motion of the knee joint. | Baseline till 72 hours after the beginning of study drug administration |
| Subjects' satisfaction rating | 72 hours |
| Investigators' satisfaction rating | 72 hours |
| D000588 |
| Amines |