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

Jiangsu HengRui Medicine Co., Ltd.108 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

108

Conditions

Pain

Interventions

SHR8554 Injection and SHR0410 InjectionDRUG

Treatment group A: SHR8554 Injection and SHR0410 Injection; high dose

SHR8554 Injection and SHR0410 InjectionDRUG

Treatment group B: SHR8554 Injection and SHR0410 Injection; low dose

SHR8554 Injection and Placebo for SHR0410 InjectionDRUG

Treatment group C: SHR8554 Injection and Placebo for SHR0410 Injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. Random blood glucose ≥11.1mmol/L 6. Subjects with abnormal liver function 7. allergies to opioids and other medications that may be used during the trial 8. The investigators determined that other conditions were inappropriate for participation in this clinical trial

Outcomes

Primary Outcomes

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.

Time frame: 24-hours

Secondary Outcomes

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.

Time frame: 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

Time frame: 24-hours

Cumulative use of remedial analgesics from 0h to 24h

Cumulative use of remedial analgesic medication

Time frame: 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.

Time frame: 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.

Time frame: 24-hours

Central Contacts

Qin Liu

CONTACT

+0518-82342973 qin.liu@hengrui.com

Data from ClinicalTrials.gov

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