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The study is being conducted to evaluate the efficacy, and safety of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR18034 | Experimental |
| |
| ropivacaine HCl | Active Comparator |
| |
| Sodium Chloride Physiological Solution | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR18034 | Drug | HR18034 380mg |
| |
| ropivacaine HCl |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of Pain Intensity in rest state | Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 72 hours. | 0~72 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with Pain Rating Scale (NPRS)≥4 during dressing change | 0~72 hours after administration | |
| Proportion of subjects with Pain Rating Scale (NPRS)≥4 during defecation | 0~72 hours after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410000 | 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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HR18034 compared with active comparator and placebo
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| Drug |
ropivacaine HCl 75mg. |
|
| Sodium Chloride Physiological Solution | Drug | Sodium Chloride Physiological Solution 20ml |
|
| AUC of Pain Intensity in rest state | 0~24 hours after administration |
| AUC of Pain Intensity in move state | 0~24 hours,0~72 hours after administration |
| Proportion of subjects who doesn't recive rescue analgesic | 0~72 hours after administration |
| Participant's satisfaction score for analgesia treatment | 72-hours |
| Investigator's satisfaction score for analgesia treatment | 72-hours |
| D000588 |
| Amines |