A Clinical Study of the Combination of SHR8554 Injection and SHR0410 Injection for the Treatment of Pain After Abdominal Surgery.

Study Overview
=================
Brief Summary
-----------------
The primary objective is to evaluate the analgesic efficacy of the combination of SHR8554 injection and SHR0410 injection compared with SHR8554 injection in patients with acute postoperative pain following abdominal surgery

Official Title
-----------------
A Phase II, Randomized, Double-Blind Study of the Combination of SHR8554 Injection and SHR0410 Injection for the Treatment of Pain After Abdominal Surgery.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: SHR8554 Injection and SHR0410 Injection
* Drug: SHR8554 Injection and SHR0410 Injection
* Drug: SHR8554 Injection and Placebo for SHR0410 Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able and willing to provide a written informed consent Subjects requiring elective general anesthesia abdominal surgery Conform to the ASA Physical Status Classification Exclusion Criteria: Subjects with a history of difficult airway Subjects with a history of reflux esophagitis Subjects with a history of mental illness Subjects with poor blood pressure control Random blood glucose ≥11.1mmol/L Subjects with abnormal liver function allergies to opioids and other medications that may be used during the trial The investigators 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A: SHR8554 Injection and SHR0410 Injection<br> | Drug: SHR8554 Injection and SHR0410 Injection<br>* Treatment group A: SHR8554 Injection and SHR0410 Injection; high dose<br>|
| Experimental: Treatment group B: SHR8554 Injection and SHR0410 Injection<br> | Drug: SHR8554 Injection and SHR0410 Injection<br>* Treatment group B: SHR8554 Injection and SHR0410 Injection; low dose<br>|
| Placebo Comparator: Treatment group C: SHR8554 Injection and Placebo for SHR0410 Injection<br> | Drug: SHR8554 Injection and Placebo for SHR0410 Injection<br>* Treatment group C: SHR8554 Injection and Placebo for SHR0410 Injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Sum of Pain Intensity Differences in Pain Score Over 24 Hours | 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 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS. | 24-hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Sum of Pain Intensity Differences in Pain Score Over 6、12、12-24 Hours | time weighted sum of pain intensity differences (SPID) divided by a constant (6、12、12-24 hours) to yield values on the 0-10 NPRS. | 6-hours、12-hours、12-24 hours | 
| Time of first use of remedial analgesic medication | The first time to use remedial analgesic medication for injection | 24-hours | 
| Cumulative use of remedial analgesics from 0h to 24h | Cumulative use of remedial analgesic medication | 24-hours | 
| Participant ' satisfaction score for analgesia treatment | Participants recalled the postoperative analgesia effect and rated their satisfaction on a scale of 0 to 10, with 0 representing dissatisfied and 10 representing very satisfied. | 24-hours | 
| Investigator satisfaction score for analgesia treatment | Postoperative analgesia was evaluated by investigators.The scale ranges from 0 to 10, with 0 being dissatisfied and 10 being very satisfied. | 24-hours |