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UNKNOWNPHASE1

A Trial of HR18034 in Inguinal Hernia Repair

A Phase I Study to Evaluate the Safety, Pharmacokinetics and Efficacy of HR18034 for Pain Management After Inguinal Hernia Repair

NCT04551924•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

Summary

Phase I, randomized, double-blind, comparator-controlled study to assess the safety, PK, and efficacy of single postsurgical application of HR18034 compared with Naropin®

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Able and willing to provide a written informed consent 2、Male or female between 18 and 70 years of age 3、Scheduled to undergo a primary, inguinal hernia repair with mesh, and be able to use the anesthesia regimen 4、Meet the body mass 5、Conform to the ASA Physical Status Classification

Exclusion Criteria

•1. Clinically significant abnormal clinical laboratory test value
•2. Subjects with poor blood pressure control after medication
•3. Subjects with atrioventricular block or cardiac insufficiency
•4. Subjects with a history of myocardial infarction or unstable angina pectoris
•5. Subjects with a history of ischemic stroke or transient ischemic attack
•6. Combination of other pain conditions that may affect postoperative pain assessment
•7. Allergic to a drug ingredient or component
•8. Persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer
•9. History of alcohol abuse or prescription and/or illicit drug abuse within 1 years
•10. Subjects with special diets (including tobacco, grapefruit and caffeine)
+9 more criteria

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

October 1, 2020

Primary Completion Date

May 30, 2021

Completion Date

May 30, 2021

Last Updated

September 16, 2020

Enrollment

ESTIMATED participants

Conditions

Inguinal Hernia Repair

Interventions

HR18034

DRUG

Naropin

DRUG

Contacts

Weidong Mi, PhD

CONTACT

010-66937116 wwdd1962@aliyun.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 16, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Trial of HR18034 in Inguinal Hernia Repair

Inclusion Criteria

Exclusion Criteria

Robotic Minimally Invasive Inguinal Hernia Repair Post-Market Clinical Study With the DEXTER Robotic System

Transversalis Fascia Plane Block for Laparoscopic Inguinal Hernia Repair

Laparoscopic Inguinal Hernia Repair TEP vs TAPP

The Effect of Cold Vapor on Dyspnea, Thirst, Nausea, and Physiological Parameters in the PACU After Laparoscopic Inguinal Hernia Surgery

Emergency Hernia Repair

The Effects of Abdominal Plane Blocks on Postoperative Quality of Recovery