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

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: SHR8554 Injection; Drug: Placebo; Drug: Morphine

• Registration Number: NCT04766463
• 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 abdominal surgery

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-23
• Study Start: 2021-03-03
• Primary Completion: 2021-10-19
• Study Completion: 2021-11-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-04
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 528

Inclusion Criteria

1. Able and willing to provide a written informed consent
2. Subjects requiring elective general anesthesia abdominal 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 Injection	-
Treatment group B	SHR8554 Injection	-
Treatment group C	Placebo	-
Treatment group D	Morphine	-

Primary Outcome Measures

Name	Time	Method
the Sum of Pain Intensity Differences in Pain Score Over 24 Hours	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.

Secondary Outcome Measures

Name	Time	Method
Time of first use of remedial analgesic medication	24-hours	The first time to use parecoxib sodium for injection
Cumulative use of remedial analgesics from 0h to 24h	24-hours	Cumulative use of parecoxib sodium for injection / sufentanil hydrochloride injection
the Sum of Pain Intensity Differences in Pain Score Over 6、12、18 、12-18 Hours	6-hours、12-hours、18-hours、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.
Participant ' satisfaction score for analgesia treatment	24-hours	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.
Investigator satisfaction score for analgesia treatment	24-hours	Postoperative analgesia was evaluated by investigators.The scale ranges from 0 to 10, with 0 being dissatisfied and 10 being very satisfied.

Trial Locations

Locations (1)

Union Hospital Affiliated to Tongji Medical Collage Huazhong University of Science and Technology; 🇨🇳 Wuhan, Wuhan, China