Clinical trial NCT05561309: Phase Ⅱ Study of Adductor Canal Block With HR18034 for Postsurgical Pain Management
Official title: A Phase Ⅱ Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Single Injection Adductor Canal Block With HR18034 for Postoperative Pain Management
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Total Knee Arthroplasty
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-09-30
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: HR18034 compared with active comparator
Primary purpose: SUPPORTIVE_CARE

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 compared with ropivacaine.


Eligibility criteria: 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 18-75 years inclusive
4. Body mass index (BMI) 18-28 kg/m2 inclusive
5. American Society of Anesthesiologists (ASA) Physical Status Classification Ⅰ\~Ⅱ

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. Subjects with special diets (including tobacco, grapefruit and caffeine)
13. Pregnant or nursing women
14. No birth control during the specified period of time
15. Participated in clinical trials of other drugs (received experimental drugs)
16. The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Primary outcomes:
measure: AUC0-72 of the NRS-R pain intensity scores.
timeFrame: 0 to 72 hours
Secondary outcomes:
measure: AUC of the NRS-R pain intensity scores.
timeFrame: 0-24, 0-48 hours
measure: AUC of the NRS-A pain intensity scores.
timeFrame: 0-24, 0-48, 0-72 hours
measure: Pain intensity assessed using an 11-point NRS ranging.
timeFrame: Baseline till 72 hours after the beginning of study drug administration
measure: Proportion of subjects who used no rescue opioid analgesic.
timeFrame: 0-24, 24-48, 48-72, 0-72 hours
measure: Total rescue analgesic consumption.
timeFrame: 0-24, 24-48, 48-72, 0-72 hours
measure: Time to the first postoperative use of rescue opioid analgesics.
timeFrame: 0-72hours
measure: Quadriceps muscle strength score.
timeFrame: Baseline till 72 hours after the beginning of study drug administration
measure: Subjects' satisfaction rating
timeFrame: 72 hours
measure: Investigators' satisfaction rating
timeFrame: 72 hours
Other outcomes:
Locations:
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
Study officials:
References: