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

NCT06509958 | Terminated Phase 2

• 1 other identifier: HR18034-204
• Study Type: interventional
• Target: 15
• 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 in total knee arthroplasty compared with ropivacaine.

Conditions

Postoperative Pain Management in Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• AUC0-72h of the NRS-A pain intensity scores.

  AUC of NRS pain intensity scores at activity (NRS-A) through 72 hours after the beginning of study drug administration.

  0 to 72 hours

Secondary Outcomes (11)

• AUC of the NRS-A pain intensity scores.

  0-24, 0-48hours

• AUC of the NRS-R pain intensity scores.

  0-24, 0-48，0-72 hours

• AUC of NRS pain intensity scores at rest (NRS-R) for time periods 0-24, 0-48 ,0-72 hours.

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

• Pain intensity assessed using an 12-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

Study Arms (3)

Dose 1

EXPERIMENTAL

Drug: HR18034

Dose 2

EXPERIMENTAL

Drug: HR18034

Ropivacaine Hydrochloride Injection

ACTIVE COMPARATOR

Drug: Ropivacaine Hydrochloride Injection

Interventions

HR18034 DRUG

HR18034

Dose 1; Dose 2

Ropivacaine Hydrochloride Injection DRUG

Ropivacaine Hydrochloride Injection

Ropivacaine Hydrochloride Injection

Eligibility Criteria

• Age: 18 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 years
• Body mass index (BMI) ≥ 18 kg/m2
• American Society of Anesthesiologists (ASA) Physical Status Classification Ⅰ\~Ⅲ

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
• Pregnant or nursing women
• No birth control during the specified period of time
• Participated in clinical trials of other drugs (received experimental drugs)
• The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

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

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: August 20, 2024
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Locations

CN (1)