A Trial of SHR0410 Injection in Postsurgical Pain Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-09

Study Completion Date

2023-05-31

Brief Summary

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The study is being conducted to evaluate the efficacy, safety of SHR0410 Injection and to explore the reasonable of SHR0410 Injection for Pain Management after Orthopaedic Surgery.

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Detailed Description

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Conditions

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Postsurgical Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

SHR0410 Injection compared with placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SHR0410 Injection High dose

Group Type EXPERIMENTAL

SHR0410 Injection

Intervention Type DRUG

SHR0410 Injection

SHR0410 Injection Low dose

Group Type EXPERIMENTAL

SHR0410 Injection

Intervention Type DRUG

SHR0410 Injection

Placebo for SHR0410 Injection

Group Type PLACEBO_COMPARATOR

Placebo for SHR0410 Injection

Intervention Type DRUG

SHR0410 Injection blank preparation

Interventions

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SHR0410 Injection

Intervention Type DRUG

Placebo for SHR0410 Injection

SHR0410 Injection blank preparation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Able and willing to provide a written informed consent；
2. Subjects requiring elective general anesthesia orthopedic surgery；
3. Male or female；
4. Meet the body mass index standard；
5. Conform to the ASA Physical Status Classification；
6. Negative pregnancy test.

Exclusion Criteria

1. Subjects with a history of myocardial infarction or unstable angina pectoris；
2. Subjects with atrioventricular block or cardiac insufficiency；
3. Subjects with a history of malignancy ；
4. Subjects with a history of stroke；
5. Subjects with a history of mental illness；
6. Subjects with a history of difficult airway；
7. Random blood glucose ≥11.1mmol/L；
8. Subjects with poor blood pressure control；
9. Abnormal values in liver or renal function；
10. Subject with a history of substance abuse and drug abuse；
11. Allergic to drugs that may be used during the study；
12. Use other drugs that affect the analgesic effect before randomization, and the time from the last use to randomization is shorter than 5 half-lives；
13. Participated in clinical trials of other drugs (received experimental drugs)；
14. Other circumstances that the investigator judged inappropriate for participation in this clinical trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No