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

Phase 2

• Conditions: Pain
• Interventions: Drug: SHR8554; Drug: Saline Solution; Drug: Morphine

• Registration Number: NCT04794738
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-12
• Study Start: 2021-04-18
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-12
• Primary Completion: 2021-10-30
• Study Completion: 2021-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

1. Able and willing to provide a written informed consent
2. Subjects requiring elective general anesthesia orthopedic surgery
3. Conform to the ASA Physical Status Classification

Exclusion Criteria

1. Subjects with a history of difficult airway
2. Subjects with a history of reflux esophagitis
3. Subjects with a history of mental illness
4. Subjects with poor blood pressure control
5. Transcutaneous oxygen saturation (SpO2) <90%
6. Random blood glucose ≥11.1mmol/L
7. Subjects with abnormal liver function
8. allergies to opioids and other medications that may be used during the trial
9. Pregnant or nursing women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A	SHR8554	-
Treatment group B	SHR8554	-
Treatment group C	Saline Solution	-
Treatment group D	Morphine	-

Primary Outcome Measures

Name	Time	Method
the Sum of Pain Intensity Differences in Pain Score Over 48 Hours in the rest state	48-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 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.

Secondary Outcome Measures

Name	Time	Method
Time of first use of remedial analgesic medication	48-hours
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
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

Trial Locations

Locations (1)

Shanghai Jiaotong University School of Medicine,Renji Hospital; 🇨🇳 Shanghai, Shanghai, China