Postoperative Pain Management in Total Knee Arthroplasty
Conditions
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.
Interventions
DRUGHR18034
HR18034
Ropivacaine Hydrochloride Injection
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able and willing to provide a written informed consent 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
1. Subjects with deformity of the involving operative limb, or other neuropathy 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| AUC of the NRS-R pain intensity scores. | 0-24, 0-48，0-72 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 | — |
| Total rescue analgesic consumption. | 0-24, 24-48, 48-72, 0-72 hours | — |
| 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. |
| Quadriceps muscle strength score. | Baseline till 72 hours after the beginning of study drug administration | — |
| Range of motion of the knee joint. | Baseline till 72 hours after the beginning of study drug administration | — |
| Subjects' satisfaction rating | 72 hours | — |
| Investigators' satisfaction rating | 72 hours | — |
| Time to the first postoperative use of rescue opioid analgesics. | 0-72hours | — |
Countries
China
Outcome results
None listed