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

NCT ID: NCT05561309

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-20
• Study Completion Date: 2024-12-31

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.

Conditions

Total Knee Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

dose 1

Experimental: HR18034 190mg (10ml)

Intervention: Drug: HR18034

Active Comparator: Ropivacaine Hydrochloride Injection

Ropivacaine Hydrochloride Injection 50mg (10mL)

Intervention: Drug: Ropivacaine Hydrochloride Injection

Group Type: EXPERIMENTAL

HR18034;Ropivacaine Hydrochloride Injection

Intervention Type: DRUG

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

dose 2

Experimental: HR18034 285mg (15ml)

Intervention: Drug: HR18034

Active Comparator: Ropivacaine Hydrochloride Injection

Ropivacaine Hydrochloride Injection 75mg (15mL)

Intervention: Drug: Ropivacaine Hydrochloride Injection

Group Type: EXPERIMENTAL

HR18034;Ropivacaine Hydrochloride Injection

Intervention Type: DRUG

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

dose 3

Experimental:HR18034 380mg (20ml)

Intervention: Drug: HR18034

Active Comparator: Ropivacaine Hydrochloride Injection

Ropivacaine Hydrochloride Injection 100mg (20mL)

Intervention: Drug: Ropivacaine Hydrochloride Injection

Group Type: EXPERIMENTAL

HR18034;Ropivacaine Hydrochloride Injection

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dongguan People's Hospital

Dongguan, Guangdong, China

Countries

China

Other Identifiers

HR18034-201

Identifier Type: -

Identifier Source: org_study_id