A Clinical Study of SHR8554 Injection for the Treatment of Pain After Orthopedic 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 orthopedic surgery.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: SHR8554
* Drug: SHR8554
* Drug: Saline Solution
* 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 orthopedic 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: 70 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<br>* SHR8554 Injection; high dose<br>|
| Experimental: Treatment group B<br> | Drug: SHR8554<br>* SHR8554 Injection; low dose<br>|
| Placebo Comparator: Treatment group C<br> | Drug: Saline Solution<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 48 Hours in the 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 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NPRS. | 48-hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Sum of Pain Intensity Differences in Pain Score Over 6、12、48 、12-24、24-48 Hours under static condition |  | 48-hours | 
| the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under moving condition |  | 48-hours | 
| Time of first use of remedial analgesic medication |  | 48-hours | 
| Cumulative use of remedial analgesics from 0h to 48h |  | 48-hours | 
| Participant ' satisfaction score for analgesia treatment |  | 48-hours | 
| Investigator satisfaction score for analgesia treatment |  | 48-hours |