Phase Ⅱ Study of Adductor Canal Block With HR18034 for Postsurgical Pain Management in TKA
Phase 2
Terminated
- Conditions
- Postoperative Pain Management in Total Knee Arthroplasty
- Interventions
- Registration Number
- NCT06509958
- Lead Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- 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 management in total knee arthroplasty compared with ropivacaine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ropivacaine Hydrochloride Injection Ropivacaine Hydrochloride Injection - Dose 2 HR18034 - Dose 1 HR18034 -
- Primary Outcome Measures
Name Time Method AUC0-72h of the NRS-A pain intensity scores. 0 to 72 hours AUC of NRS pain intensity scores at activity (NRS-A) through 72 hours after the beginning of study drug administration.
- Secondary Outcome Measures
Name Time Method Subjects' satisfaction rating 72 hours Investigators' satisfaction rating 72 hours AUC of NRS pain intensity scores at rest (NRS-R) for time periods 0-24, 0-48 ,0-72 hours. 0-24, 0-48 ,0-72 hours. Pain intensity assessed using an 12-point NRS ranging. Baseline till 72 hours after the beginning of study drug administration Proportion of subjects who used no rescue opioid analgesic. 0-24, 24-48, 48-72, 0-72 hours Quadriceps muscle strength score. Baseline till 72 hours after the beginning of study drug administration Total rescue analgesic consumption. 0-24, 24-48, 48-72, 0-72 hours Range of motion of the knee joint. Baseline till 72 hours after the beginning of study drug administration AUC of the NRS-A pain intensity scores. 0-24, 0-48hours AUC of NRS pain intensity scores at activity (NRS-A) for time periods 0-24, 0-48 hours.
AUC of the NRS-R pain intensity scores. 0-24, 0-48，0-72 hours Time to the first postoperative use of rescue opioid analgesics. 0-72hours
Trial Locations
- Locations (1)
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China