Phase Ⅱ Study of Adductor Canal Block With HR18034 for Postsurgical Pain Management in TKA

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

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.

Study Overview

• Status: Terminated
• Conditions: Postoperative Pain Management in Total Knee Arthroplasty
• Intervention / Treatment: Drug: HR18034; Drug: Ropivacaine Hydrochloride Injection

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Tianjin Medical University General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose 1	Drug: HR18034; HR18034
Experimental: Dose 2	Drug: HR18034; HR18034
Active Comparator: Ropivacaine Hydrochloride Injection	Drug: Ropivacaine Hydrochloride Injection; Ropivacaine Hydrochloride Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-72h of the NRS-A pain intensity scores.	AUC of NRS pain intensity scores at activity (NRS-A) through 72 hours after the beginning of study drug administration.	0 to 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC of the NRS-A pain intensity scores.	AUC of NRS pain intensity scores at activity (NRS-A) for time periods 0-24, 0-48 hours.	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.
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
Time to the first postoperative use of rescue opioid analgesics.		0-72hours
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

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2024
• Primary Completion (Actual): October 10, 2024
• Study Completion (Actual): October 10, 2024

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): October 30, 2024
• Last Update Submitted That Met QC Criteria: October 28, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Ropivacaine
• Other Study ID Numbers: HR18034-204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No