A Phase Ⅱ Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Single Injection Intercostal Nerve Block With HR18034 for Postoperative Pain Management

Shanghai Hengrui Pharmaceutical Co., Ltd.1 site in 1 country96 target enrollmentFebruary 21, 2023

ConditionsThoracoscopic Lobectomy

InterventionsHR18034 Ropivacaine Hydrochloride Injection

DrugsHR18034 Ropivacaine Hydrochloride Injection

Overview

Phase: Phase 2
Intervention: HR18034
Conditions: Thoracoscopic Lobectomy
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Enrollment: 96
Locations: 1
Primary Endpoint: AUC0-72 of the NRS-A (or cough) pain intensity scores.
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Phase Ⅱ, randomized, double-blind, comparator-controlled study to evaluate the efficacy, safety and pharmacokinetics of single injection intercostal nerve block with HR18034 for postoperative pain management compared with ropivacaine.

Registry

clinicaltrials.gov

Start Date

February 21, 2023

End Date

June 30, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Able and willing to provide a written informed consent
•Scheduled to undergo thoracoscopic lobectomy under general anesthesia.
•Male or female, aged 18 years and older inclusive
•Body mass index (BMI) 18-30 kg/m2 inclusive
•American Society of Anesthesiologists (ASA) Physical Status Classification Ⅰ\~Ⅱ

Exclusion Criteria

•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
•Combination with ventilation disorders caused by airway or spinal anatomical factors, bronchiectasis, and severe chest adhesions on the surgical side
•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)

Arms & Interventions

HR18034

Intervention: HR18034

Ropivacaine Hydrochloride Injection

Intervention: Ropivacaine Hydrochloride Injection

Outcomes

Primary Outcomes

AUC0-72 of the NRS-A (or cough) pain intensity scores.

Time Frame: 0 to 72 hours

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

Secondary Outcomes

Total rescue analgesic consumption.(0-24, 24-48, 48-72, 0-72 hours)
AUC of the NRS-A (or cough) pain intensity scores.(0-12, 12-24,12-48, 12-72 hours)
AUC of the NRS-R pain intensity scores.(0-12, 12-24,12-48, 12-72, 0-72 hours)
Proportion of subjects who used no rescue opioid analgesic.(0-24, 24-48, 48-72, 0-72 hours)
Time to the first postoperative use of rescue opioid analgesics.(0-72 hours)
Subjects' satisfaction rating(72 hours)
Investigators' satisfaction rating(72 hours)