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

Study Overview
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Brief Summary
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The primary objective is to evaluate the analgesic efficacy of IV SHR8554 compared with placebo and morphine in patients with acute postoperative pain following abdominal surgery

Official Title
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A Phase III, Randomized, Double-Blind, Placebo- and Active-controlled Study of SHR8554 Injection for the Treatment of Pain After Abdominal Surgery.

Conditions
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Pain

Intervention / Treatment
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* Drug: SHR8554 Injection
* Drug: SHR8554 Injection
* Drug: Placebo
* Drug: Morphine


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 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 Transcutaneous oxygen saturation (SpO2) <90% Random blood glucose ≥11.1mmol/L Subjects with abnormal liver function allergies to opioids and other medications that may be used during the trial Pregnant or nursing women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A<br> | Drug: SHR8554 Injection<br>* SHR8554 Injection; high dose<br>|
| Experimental: Treatment group B<br> | Drug: SHR8554 Injection<br>* SHR8554 Injection; low dose<br>|
| Placebo Comparator: Treatment group C<br> | Drug: Placebo<br>* Saline Solution<br>|
| Active Comparator: Treatment group D<br> | Drug: Morphine<br>* Morphine<br>|

What is the study measuring?
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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、18 、12-18 Hours | time weighted sum of pain intensity differences (SPID) divided by a constant (6、12、18 、12-18 hours) to yield values on the 0-10 NPRS. | 6-hours、12-hours、18-hours、12-18 hours | 
| Time of first use of remedial analgesic medication | The first time to use parecoxib sodium for injection | 24-hours | 
| Cumulative use of remedial analgesics from 0h to 24h | Cumulative use of parecoxib sodium for injection / sufentanil hydrochloride injection | 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 |