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

NCT05561309 | Active Not Recruiting Phase 2

• 1 other identifier: HR18034-201
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• AUC of the NRS-R pain intensity scores.

  0-24, 0-48 hours

• AUC of the NRS-A pain intensity scores.

  0-24, 0-48, 0-72 hours

• Pain intensity assessed using an 11-point NRS ranging.

  Baseline till 72 hours after the beginning of study drug administration

• Proportion of subjects who used no rescue opioid analgesic.

  0-24, 24-48, 48-72, 0-72 hours

• Total rescue analgesic consumption.

  0-24, 24-48, 48-72, 0-72 hours

Study Arms (3)

dose 1

EXPERIMENTAL

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

dose 2

EXPERIMENTAL

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

dose 3

EXPERIMENTAL

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

Interventions

HR18034;Ropivacaine Hydrochloride Injection 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 1; dose 2; dose 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent
• Scheduled to undergo primary unilateral total knee arthroplasty under general anesthesia.
• Male or female，aged 18-75 years inclusive
• Body mass index (BMI) 18-28 kg/m2 inclusive
• American Society of Anesthesiologists (ASA) Physical Status Classification Ⅰ\~Ⅱ

You may not qualify if:

• Subjects with deformity of the involving operative limb, or other neuropathy
• Subjects with a history of new myocardial infarction or unstable angina within 6 months prior to randomization;
• Subjects with a history of ischemic stroke or transient ischemic attack (TIA)
• Subjects with a history of mental system diseases and cognitive dysfunction
• Combination of other pain conditions that may affect postoperative pain assessment
• Persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer
• Subjects with a history of deep vein thrombosis-related disease
• Clinically significant abnormal clinical laboratory test value
• Allergic to a drug ingredient or component
• 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
• History of alcohol abuse or prescription and/or illicit drug abuse
• Subjects with special diets (including tobacco, grapefruit and caffeine)
• Pregnant or nursing women
• No birth control during the specified period of time
• Participated in clinical trials of other drugs (received experimental drugs)

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Dongguan People's Hospital

Dongguan, Guangdong, 523059, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HR18034 compared with active comparator

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: September 30, 2022
• Study Start: October 20, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-03

Locations

CN (1)