NCT05744674

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

February 21, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 15, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

February 16, 2023

Last Update Submit

March 12, 2023

Conditions

Thoracoscopic Lobectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • Total rescue analgesic consumption.

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

  • Time to the first postoperative use of rescue opioid analgesics.

    0-72 hours

  • +2 more secondary outcomes

Study Arms (2)

HR18034

EXPERIMENTAL
Drug: HR18034

Ropivacaine Hydrochloride Injection

ACTIVE COMPARATOR
Drug: Ropivacaine Hydrochloride Injection

Interventions

HR18034DRUG

HR18034 228mg/342mg/456mg

HR18034
Ropivacaine Hydrochloride InjectionDRUG

Ropivacaine Hydrochloride Injection 60mg/90mg/120mg

Ropivacaine Hydrochloride Injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Qin Liu

CONTACT

+0518-82342973qin.liu@hengrui.com

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
Model Details: HR18034 compared with active comparator
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2023

First Posted

February 27, 2023

Study Start

February 21, 2023

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

March 15, 2023

Record last verified: 2023-02

Locations

CN(1)