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

Phase 2

Active, not recruiting

• Conditions: Total Knee Arthroplasty
• Interventions: Drug: HR18034;Ropivacaine Hydrochloride Injection

• Registration Number: NCT05561309
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-30
• Study Start: 2022-10-20
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-01
• Last Update Posted: 2024-03-04
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 89

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dose 2	HR18034;Ropivacaine Hydrochloride Injection	Experimental: HR18034 285mg (15ml) Intervention: Drug: HR18034 Active Comparator: Ropivacaine Hydrochloride Injection Ropivacaine Hydrochloride Injection 75mg (15mL) Intervention: Drug: Ropivacaine Hydrochloride Injection
dose 3	HR18034;Ropivacaine Hydrochloride Injection	Experimental:HR18034 380mg (20ml) Intervention: Drug: HR18034 Active Comparator: Ropivacaine Hydrochloride Injection Ropivacaine Hydrochloride Injection 100mg (20mL) Intervention: Drug: Ropivacaine Hydrochloride Injection
dose 1	HR18034;Ropivacaine Hydrochloride Injection	Experimental: HR18034 190mg (10ml) Intervention: Drug: HR18034 Active Comparator: Ropivacaine Hydrochloride Injection Ropivacaine Hydrochloride Injection 50mg (10mL) Intervention: Drug: Ropivacaine Hydrochloride Injection

Primary Outcome Measures

Name	Time	Method
AUC0-72 of the NRS-R pain intensity scores.	0 to 72 hours	AUC of NRS pain intensity scores at rest (NRS-R) through 72 hours after the beginning of study drug administration.

Secondary Outcome Measures

Name	Time	Method
Time to the first postoperative use of rescue opioid analgesics.	0-72hours	Time to the first postoperative use of rescue opioid analgesics 0-72 hours after the beginning of study drug administration.
Subjects' satisfaction rating	72 hours	Subjects' satisfaction rating with postsurgical pain control at 72 hours.
Pain intensity assessed using an 11-point NRS ranging.	Baseline till 72 hours after the beginning of study drug administration	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
Proportion of subjects who used no rescue opioid analgesic.	0-24, 24-48, 48-72, 0-72 hours	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.
Total rescue analgesic consumption.	0-24, 24-48, 48-72, 0-72 hours	Total rescue analgesic consumption through 0-24, 24-48, 48-72 and 0-72 hours after the beginning of study drug administration.
AUC of the NRS-R pain intensity scores.	0-24, 0-48 hours	AUC of NRS pain intensity scores at rest (NRS-R) for time periods 0-24, 0-48 hours.
AUC of the NRS-A pain intensity scores.	0-24, 0-48, 0-72 hours	AUC of NRS pain intensity scores at activity (NRS-A) for time periods 0-24, 0-48, 0-72 hours.
Quadriceps muscle strength score.	Baseline till 72 hours after the beginning of study drug administration	Quadriceps muscle strength score at 6, 8, 12, 16, 20, 24, 36, 48 and 72 hours.
Investigators' satisfaction rating	72 hours	Investigators' satisfaction rating with postsurgical pain control at 72 hours.

Trial Locations

Locations (1)

Dongguan People's Hospital; 🇨🇳 Dongguan, Guangdong, China