A Phase Ⅱ Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Single Injection Adductor Canal Block With HR18034 for Postoperative Pain Management in Total Knee Arthroplasty

Shanghai Hengrui Pharmaceutical Co., Ltd.1 site in 1 country15 target enrollmentAugust 20, 2024

ConditionsPostoperative Pain Management in Total Knee Arthroplasty

InterventionsHR18034 Ropivacaine Hydrochloride Injection

DrugsHR18034 Ropivacaine Hydrochloride Injection

Overview

Phase: Phase 2
Intervention: HR18034
Conditions: Postoperative Pain Management in Total Knee Arthroplasty
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Enrollment: 15
Locations: 1
Primary Endpoint: AUC0-72h of the NRS-A pain intensity scores.
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 20, 2024

End Date

October 10, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Dose 1

Intervention: HR18034

Dose 2

Intervention: HR18034

Ropivacaine Hydrochloride Injection

Intervention: Ropivacaine Hydrochloride Injection

Outcomes

Primary Outcomes

AUC0-72h of the NRS-A pain intensity scores.

Time Frame: 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 Outcomes

Subjects' satisfaction rating(72 hours)
Investigators' satisfaction rating(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 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.)
Time to the first postoperative use of rescue opioid analgesics.(0-72hours)