A Trial of SHR0410 Injection for the Treatment of Pain After Endoscopic Surgery of the Lower Abdominal

Phase 3CompletedNCT04852003

Jiangsu HengRui Medicine Co., Ltd.228 enrolled

Overview

The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after endoscopic surgery of the lower abdominal.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

228

Conditions

Pain

Interventions

SHR0410 InjectionDRUG

SHR0410 Injection

PlaceboDRUG

Placebo for SHR0410 Injection

MorphineDRUG

Morphine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Able and willing to provide a written informed consent 2. Subjects requiring elective general anesthesia endoscopic surgery of the lower abdominal 3. Male or female 4. Meet the body mass index standard 5. Conform to the ASA Physical Status Classification Exclusion Criteria 1. Subjects with a history of difficult airway 2. Subjects with a history of mental illness 3. Subjects with a history of cognitive impairment epilepsy 4. Subjects with a history of myocardial infarction or unstable angina pectoris 5. Subjects with atrioventricular block or cardiac insufficiency 6. Subjects with a history of ischemic stroke or transient ischemic attack 7. Subjects with poor blood pressure control after medication 8. Subject with a history of substance abuse and drug abuse 9. Abnormal values in liver function 10. Subjects with an oxygen saturation below 90% on room air 11. Allergic to drugs that may be used during the study 12. Pregnant or nursing women 13. No birth control during the specified period of time 14. Participated in clinical trials of other drugs (received experimental drugs) 15. The investigators determined that other conditions were inappropriate for participation in this clinical trial

Locations (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

The area under the curve of pain intensity over 24 hours

Pain intensity will be evaluated using an 11-point (0-10) numeric rating scale (NRS), with higher numbers indicating a higher pain intensity, administered over 24 hours.

Time frame: 24-hours

Secondary Outcomes

Total consumption of remedial analgesics from 0h to 24h

Total consumption of IV morphine

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

Frequency and severity of adverse events

Assessed by monitoring of adverse events. Participants with adverse events found to be related to the study drug will be compared to those receiving placebo or active comparator.

Time frame: Day 4（or early termination on Day 3）

Safety as assessed by vital signs

Changes in vital signs such as body temperature, blood pressure, heart rate will be assessed at specified times.

Time frame: Day 4（or early termination on Day 3）

Safety as assessed by laboratory evaluations

Assessed by laboratory evaluations at specified times. Participants with clinically significant lab values will be compared to those receiving placebo or active comparator.

Data from ClinicalTrials.gov

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