Phase Ⅱ Study of Adductor Canal Block With HR18034 for Postsurgical Pain Management in TKA
NCT ID: NCT06509958
Last Updated: 2024-10-30
Study Results
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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TERMINATED
PHASE2
15 participants
INTERVENTIONAL
2024-08-20
2024-10-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dose 1
HR18034
HR18034
Dose 2
HR18034
HR18034
Ropivacaine Hydrochloride Injection
Ropivacaine Hydrochloride Injection
Ropivacaine Hydrochloride Injection
Interventions
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HR18034
HR18034
Ropivacaine Hydrochloride Injection
Ropivacaine Hydrochloride Injection
Eligibility Criteria
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Inclusion Criteria
2. Scheduled to undergo primary unilateral total knee arthroplasty under general anesthesia.
3. Male or female，aged ≥ 18 years
4. Body mass index (BMI) ≥ 18 kg/m2
5. American Society of Anesthesiologists (ASA) Physical Status Classification Ⅰ\~Ⅲ
Exclusion Criteria
2. Subjects with a history of new myocardial infarction or unstable angina within 6 months prior to randomization;
3. Subjects with a history of ischemic stroke or transient ischemic attack (TIA)
4. Subjects with a history of mental system diseases and cognitive dysfunction
5. Combination of other pain conditions that may affect postoperative pain assessment
6. Persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer
7. Subjects with a history of deep vein thrombosis-related disease
8. Clinically significant abnormal clinical laboratory test value
9. Allergic to a drug ingredient or component
10. Use of any of medications, which affect drug metabolism or analgesia evaluation, within 5 half-lives or as specified prior to the study surgical procedure
11. History of alcohol abuse or prescription and/or illicit drug abuse
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 inestigators determined that other conditions were inappropriate for participation in this clinical trial
18 Years
ALL
No
Sponsors
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Shanghai Hengrui Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Countries
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Other Identifiers
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HR18034-204
Identifier Type: -
Identifier Source: org_study_id
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