Status:
TERMINATED
Phase Ⅱ Study of Adductor Canal Block With HR18034 for Postsurgical Pain Management in TKA
Lead Sponsor:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Conditions:
Postoperative Pain Management in Total Knee Arthroplasty
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Phase Ⅱ, randomized, double-blind, comparator-controlled study to evaluate the efficacy, safety and pharmacokinetics of single injection adductor canal block with HR18034 for postoperative pain manage...
Eligibility Criteria
Inclusion
- Able and willing to provide a written informed consent
- Scheduled to undergo primary unilateral total knee arthroplasty under general anesthesia.
- Male or female，aged ≥ 18 years
- Body mass index (BMI) ≥ 18 kg/m2
- American Society of Anesthesiologists (ASA) Physical Status Classification Ⅰ\~Ⅲ
Exclusion
- Subjects with deformity of the involving operative limb, or other neuropathy
- Subjects with a history of new myocardial infarction or unstable angina within 6 months prior to randomization;
- Subjects with a history of ischemic stroke or transient ischemic attack (TIA)
- Subjects with a history of mental system diseases and cognitive dysfunction
- Combination of other pain conditions that may affect postoperative pain assessment
- Persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer
- Subjects with a history of deep vein thrombosis-related disease
- Clinically significant abnormal clinical laboratory test value
- Allergic to a drug ingredient or component
- 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
- History of alcohol abuse or prescription and/or illicit drug abuse
- Pregnant or nursing women
- No birth control during the specified period of time
- Participated in clinical trials of other drugs (received experimental drugs)
- The inestigators determined that other conditions were inappropriate for participation in this clinical trial
Key Trial Info
Start Date :
August 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06509958
Start Date
August 20 2024
End Date
October 10 2024
Last Update
October 30 2024
Active Locations (1)
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1
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052