Phase Ⅱ Study of Intercostal Nerve Block With HR18034 for Postsurgical Pain Management

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

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracoscopic Lobectomy
• Intervention / Treatment: Drug: HR18034; Drug: Ropivacaine Hydrochloride Injection

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qin Liu; Phone Number: +0518-82342973; Email: qin.liu@hengrui.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
      • Principal Investigator: Jianxing He

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Subjects with a history of new myocardial infarction or unstable angina within 6 months prior to randomization;
2. Subjects with a history of ischemic stroke or transient ischemic attack (TIA)
3. Subjects with a history of mental system diseases and cognitive dysfunction
4. Combination of other pain conditions that may affect postoperative pain assessment
5. Combination with ventilation disorders caused by airway or spinal anatomical factors, bronchiectasis, and severe chest adhesions on the surgical side
6. Clinically significant abnormal clinical laboratory test value
7. Allergic to a drug ingredient or component
8. 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
9. History of alcohol abuse or prescription and/or illicit drug abuse
10. Subjects with special diets (including tobacco, grapefruit and caffeine)
11. Pregnant or nursing women
12. No birth control during the specified period of time
13. Participated in clinical trials of other drugs (received experimental drugs)
14. The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HR18034	Drug: HR18034; HR18034 228mg/342mg/456mg
Active Comparator: Ropivacaine Hydrochloride Injection	Drug: Ropivacaine Hydrochloride Injection; Ropivacaine Hydrochloride Injection 60mg/90mg/120mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-72 of the NRS-A (or cough) 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Subjects' satisfaction rating	Subjects' satisfaction rating with postsurgical pain control at 72 hours.	72 hours
Investigators' satisfaction rating	Investigators' satisfaction rating with postsurgical pain control at 72 hours.	72 hours
AUC of the NRS-A (or cough) pain intensity scores.	AUC of NRS pain intensity scores at activity (NRS-A) or cough for time periods 0-12, 12-24, 12-48, 12-72 hours.	0-12, 12-24,12-48, 12-72 hours
AUC of the NRS-R pain intensity scores.	AUC of NRS pain intensity scores at rest (NRS-R) for time periods 0-12, 12-24,12-48, 12-72, 0-72 hours.	0-12, 12-24,12-48, 12-72, 0-72 hours
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.	0-72 hours

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2023
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 12, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: HR18034-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No