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

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05561309
• Collaborator: (none)
• Enrollment: 96
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 8.3
• Patients Per Site Per Month: 11.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Total Knee Arthroplasty	Drug: HR18034;Ropivacaine Hydrochloride Injection	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: HR18034 compared with active comparatorHR18034 compared with active comparator
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: A Phase Ⅱ Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Single Injection Adductor Canal Block With HR18034 for Postoperative Pain Management
• Actual Study Start Date: Oct 20, 2022
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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

4. 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.

5. 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.

6. 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.

7. 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.

8. Subjects' satisfaction rating [72 hours]

   Subjects' satisfaction rating with postsurgical pain control at 72 hours.

9. Investigators' satisfaction rating [72 hours]

   Investigators' satisfaction rating with postsurgical pain control at 72 hours.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dongguan People's Hospital	Dongguan	Guangdong	China	523059

Sponsors and Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Hengrui Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05561309
• Other Study ID Numbers: HR18034-201
• First Posted: Sep 30, 2022
• Last Update Posted: Nov 10, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ropivacaine

Study Results

No Results Posted as of Nov 10, 2022