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

Total Knee Arthroplasty Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05561309
• Other study ID #: HR18034-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 20, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 89
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ?~?

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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

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

Locations

Country	Name	City	State
China	Dongguan People's Hospital	Dongguan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Subjects' satisfaction rating	Subjects' satisfaction rating with postsurgical pain control at 72 hours.	72 hours
Secondary	Investigators' satisfaction rating	Investigators' satisfaction rating with postsurgical pain control at 72 hours.	72 hours