A Study of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

Study Overview
=================
Brief Summary
-----------------
The study is being conducted to evaluate the efficacy, and safety of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy.

Official Title
-----------------
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Active and Placebo Controlled Study to Evaluate the Efficacy and Safety of Local Administration of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

Conditions
-----------------
Postsurgical Pain Management

Intervention / Treatment
-----------------
* Drug: HR18034
* Drug: ropivacaine HCl
* Drug: Sodium Chloride Physiological Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able and willing to provide a written informed consent Subjects requiring hemorrhoidectomy under subarachnoid anesthesia 18 kg/m2 ≤ BMI ≤ 30 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 Spinal or spinal lesions that were determined by the investigator to be unable to tolerate subarachnoid anesthesia Subjects with a history of hemorrhoidectomy Subjects with a history of constipation Subjects with a history of perianal disease Abnormal values in the laboratory Subject with heart rate <50 or >100 beats per minute. 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 prohibited drug use Participants who may be affected by alcohol, or drug abstinence during the study 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
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HR18034<br> | Drug: HR18034<br>* HR18034 380mg<br>|
| Active Comparator: ropivacaine HCl<br> | Drug: ropivacaine HCl<br>* ropivacaine HCl 75mg.<br>|
| Placebo Comparator: Sodium Chloride Physiological Solution<br> | Drug: Sodium Chloride Physiological Solution<br>* Sodium Chloride Physiological Solution 20ml<br>|

What is the study measuring?
-----------------
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 |
| --- | --- | --- |
| 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 | 
| 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 |