Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is being conducted to evaluate the efficacy, and safety of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy. To explore the reasonable dosage of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR18034 dose 1 | Experimental |
| |
| HR18034 dose 2 | Experimental |
| |
| HR18034 dose 3 | Experimental |
| |
| ropivacaine HCl | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR18034 | Drug | HR18034 low dose |
| |
| HR18034 |
| 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 |
|---|---|---|
| AUC of Pain Intensity in rest state | AUC of Pain Intensity in rest state | 0~24 hours,0~48 hours after administration |
| AUC of Pain Intensity in move state | AUC of Pain Intensity in move state |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230000 | China | ||
| Beijing Tongren Hospital Affiliated to Capital Medical University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
HR18034 compared with active comparator
Not provided
Not provided
Not provided
| Drug |
HR18034 midium dose |
|
| HR18034 | Drug | HR18034 high dose |
|
| ropivacaine HCl. | Drug | ropivacaine HCl. |
|
| 0~24 hours,0~48 hours,0~72 hours after administration |
| Pain intensity in rest state assessed using an 11-point NPRS ranging | 11-point NPRS ranging from a score of 0 to 10 | 0~72 hours after administration |
| Pain intensity in move state assessed using an 11-point NPRS ranging | 11-point NPRS ranging from a score of 0 to 10 | 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 |
| Beijing |
| Beijing Municipality |
| 100005 |
| China |
| Dongguan people's Hospital | Dongguan | Guangdong | 523000 | China |
| Nanning Second People's Hospital | Nanning | Guangxi | 530000 | China |
| The Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | 550000 | China |
| Traditional Chinese Medicine Hospital of Hebei Province | Shijiazhuang | Hebei | 050000 | China |
| Shiyan Taihe Hospital | Shiyan | Hubei | 442099 | China |
| the first People's Hospital of Changde | Changde | Hunan | 415000 | China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410000 | China |
| Taizhou People's Hospital | Taizhou | Jiangsu | 225300 | China |
| Affiliated Zhongshan Hospital of Dalian University | Dalian | Liaoning | 116001 | China |
| General Hospital of Northern Theater Command | Shenyang | Liaoning | 110000 | China |
| Central Hospital Affiliated to Shandong First Medical University | Jinan | Shandong | 250000 | China |
| the First Affiliated Hospital of Xi'An Jiaotong University | Xi’an | Shanxi | 710061 | China |
| The First Affiliated Hospital of Xi'an Medical University | Xi’an | Shanxi | 710077 | China |
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | 610072 | China |
| Jiaxing Second Hospital | Jiaxing | Zhejiang | 314000 | China |
| Li Huili Hospital of Ningbo Medical Center | Ningbo | Zhejiang | 315040 | China |
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
Not provided
Not provided