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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Drug: HR18034;Ropivacaine Hydrochloride Injection

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Dongguan, Guangdong, China, 523059
      • Dongguan People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (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 18-75 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dose 1; Experimental: HR18034 190mg (10ml) Intervention: Drug: HR18034 Active Comparator: Ropivacaine Hydrochloride Injection Ropivacaine Hydrochloride Injection 50mg (10mL) Intervention: Drug: Ropivacaine Hydrochloride Injection	Drug: HR18034;Ropivacaine Hydrochloride Injection; Drug: HR18034 Drug: Ropivacaine Hydrochloride Injection Local nerve block of Ropivacaine Hydrochloride Injection to produce anesthesia for surgery and analgesia in postoperative pain management. Other Name: Ropivacaine Hydrochloride Injection, 0.5% Injectable Solution
Experimental: dose 2; Experimental: HR18034 285mg (15ml) Intervention: Drug: HR18034 Active Comparator: Ropivacaine Hydrochloride Injection Ropivacaine Hydrochloride Injection 75mg (15mL) Intervention: Drug: Ropivacaine Hydrochloride Injection	Drug: HR18034;Ropivacaine Hydrochloride Injection; Drug: HR18034 Drug: Ropivacaine Hydrochloride Injection Local nerve block of Ropivacaine Hydrochloride Injection to produce anesthesia for surgery and analgesia in postoperative pain management. Other Name: Ropivacaine Hydrochloride Injection, 0.5% Injectable Solution
Experimental: dose 3; Experimental:HR18034 380mg (20ml) Intervention: Drug: HR18034 Active Comparator: Ropivacaine Hydrochloride Injection Ropivacaine Hydrochloride Injection 100mg (20mL) Intervention: Drug: Ropivacaine Hydrochloride Injection	Drug: HR18034;Ropivacaine Hydrochloride Injection; Drug: HR18034 Drug: Ropivacaine Hydrochloride Injection Local nerve block of Ropivacaine Hydrochloride Injection to produce anesthesia for surgery and analgesia in postoperative pain management. Other Name: Ropivacaine Hydrochloride Injection, 0.5% Injectable Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-72 of the NRS-R pain intensity scores.	AUC of NRS pain intensity scores at rest (NRS-R) 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-R pain intensity scores.	AUC of NRS pain intensity scores at rest (NRS-R) for time periods 0-24, 0-48 hours.	0-24, 0-48 hours
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, 0-72 hours.	0-24, 0-48, 0-72 hours
Pain intensity assessed using an 11-point NRS ranging.	11-point Numercal Rating Scale ranging from a score of 0 to 10. Pain-free defined as an NRS of 0 or 1. Worst imaginable pain defined as an NRS of 10	Baseline till 72 hours after the beginning of study drug administration
Proportion of subjects who used no rescue opioid analgesic.	Proportion of subjects who used no rescue opioid analgesic through 0-24, 24-48, 48-72 and 0-72 hours after the beginning of study drug administration.	0-24, 24-48, 48-72, 0-72 hours
Total rescue analgesic consumption.	Total rescue analgesic consumption through 0-24, 24-48, 48-72 and 0-72 hours after the beginning of study drug administration.	0-24, 24-48, 48-72, 0-72 hours
Time to the first postoperative use of rescue opioid analgesics.	Time to the first postoperative use of rescue opioid analgesics 0-72 hours after the beginning of study drug administration.	0-72hours
Quadriceps muscle strength score.	Quadriceps muscle strength score at 6, 8, 12, 16, 20, 24, 36, 48 and 72 hours.	Baseline till 72 hours after the beginning of study drug administration
Subjects' satisfaction rating	Subjects' satisfaction rating with postsurgical pain control at 72 hours.	72 hours
Investigators' satisfaction rating	Investigators' satisfaction rating with postsurgical pain control at 72 hours.	72 hours

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: HR18034-201

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