A Trial of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy.

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Local Administration of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

Conditions
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Postsurgical Pain Management

Intervention / Treatment
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* Drug: HR18034
* Drug: HR18034
* Drug: HR18034
* Drug: ropivacaine HCl.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to provide a written informed consent Subjects requiring hemorrhoidectomy under subarachnoid anesthesia 18 kg/m2 ≤ BMI ≤ 28 kg/m2 Conform to the ASA Physical Status Classification Women of childbearing age have a negative pregnancy test and are not nursing Exclusion Criteria: Subjects with a history of myocardial infarction or unstable angina pectoris Subjects with atrioventricular block or cardiac insufficiency Subjects with a history of ischemic stroke or transient ischemic attack Subjects with a history of mental illness and a history of cognitive impairment epilepsy Subjects with concurrent painful physical condition that may affect postoperative pain assessment Subjects with myelopathy or spinal disease Subjects with a history of hemorrhoidectomy Abnormal values in the laboratory Subject with a history of substance abuse and drug abuse Subject with refractory hypertension History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics, opioids, or other drugs that may used in study History of substance abuse, drug use and/or alcohol abuse HBsAg, HCVAb, HIV antibody and syphilis antibody tested positive during screening period; Participated in clinical trials of other drugs (received experimental drugs) The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: HR18034 compared with active comparator
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HR18034 dose 1<br> | Drug: HR18034<br>* HR18034 low dose<br>|
| Experimental: HR18034 dose 2<br> | Drug: HR18034<br>* HR18034 midium dose<br>|
| Experimental: HR18034 dose 3<br> | Drug: HR18034<br>* HR18034 high dose<br>|
| Active Comparator: ropivacaine HCl<br> | Drug: ropivacaine HCl.<br>* ropivacaine HCl.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |