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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 compared with ropivacaine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose 1 | Experimental | Experimental: HR18034 190mg (10ml) Intervention: Drug: HR18034 Active Comparator: Ropivacaine Hydrochloride Injection Ropivacaine Hydrochloride Injection 50mg (10mL) Intervention: Drug: Ropivacaine Hydrochloride Injection |
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| dose 2 | Experimental | Experimental: HR18034 285mg (15ml) Intervention: Drug: HR18034 Active Comparator: Ropivacaine Hydrochloride Injection Ropivacaine Hydrochloride Injection 75mg (15mL) Intervention: Drug: Ropivacaine Hydrochloride Injection |
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| dose 3 | Experimental | Experimental:HR18034 380mg (20ml) Intervention: Drug: HR18034 Active Comparator: Ropivacaine Hydrochloride Injection Ropivacaine Hydrochloride Injection 100mg (20mL) Intervention: Drug: Ropivacaine Hydrochloride Injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR18034;Ropivacaine Hydrochloride Injection | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-72 of the NRS-R pain intensity scores. | AUC of NRS pain intensity scores at rest (NRS-R) through 72 hours after the beginning of study drug administration. | 0 to 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of the NRS-R pain intensity scores. | AUC of NRS pain intensity scores at rest (NRS-R) for time periods 0-24, 0-48 hours. | 0-24, 0-48 hours |
| 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, 0-72 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongguan People's Hospital | Dongguan | Guangdong | 523059 | China |
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HR18034 compared with active comparator
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| 0-24, 0-48, 0-72 hours |
| Pain intensity assessed using an 11-point NRS ranging. | 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 | Baseline till 72 hours after the beginning of study drug administration |
| 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. | 0-72hours |
| Quadriceps muscle strength score. | Quadriceps muscle strength score at 6, 8, 12, 16, 20, 24, 36, 48 and 72 hours. | Baseline till 72 hours after the beginning of study drug administration |
| 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 |