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Mirogabalin for Total Hip Arthroplasty

Primary Purpose

Hip Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Arm I (mirogabalin group)
Arm II (placebo group)
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty American Society of Anesthesiologists class 1-3 Exclusion Criteria: Major prior ipsilateral open hip surgery Allergies to drugs used in research Difficult to manage diabetes mellitus (including insulin dependence) Chronic use of gabapentin or pregabalin (regular use for more than 3 months) Patients taking cimetidine, probenecid, or lorazepam Patients with moderate or severe hepatic impairment (AST/ALT 2.5 times or more of the upper limit of normal) Estimated glomerular filtration rate < 60 mL/min/1.73m2 Dependence on opioids In the case of subjects who cannot read the consent form (e.g. illiterate, foreigners, etc.)

Sites / Locations

  • Gangnam Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

mirogabalin group

placebo group

Arm Description

perioperative mirogabalin

placebo

Outcomes

Primary Outcome Measures

numeric rating scale at flexion
A score of 0 indicates no pain and a score of 10 indicates maximum pain.

Secondary Outcome Measures

numeric rating scale at flexion
A score of 0 indicates no pain and a score of 10 indicates maximum pain.

Full Information

First Posted
June 29, 2023
Last Updated
August 10, 2023
Sponsor
Gangnam Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05938088
Brief Title
Mirogabalin for Total Hip Arthroplasty
Official Title
Mirogabalin and Pain After Total Hip Arthroplasty: a Double-blind, Randomized, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Actual)
Primary Completion Date
June 28, 2025 (Anticipated)
Study Completion Date
June 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to confirm the analgesic effect of mirogabalin in patients undergoing unilateral hip arthroplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mirogabalin group
Arm Type
Experimental
Arm Description
perioperative mirogabalin
Arm Title
placebo group
Arm Type
Sham Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Arm I (mirogabalin group)
Intervention Description
Take two capsules of Mirogabalin 5 mg within 30 minutes before going to the operating room. Patients take 5 mg of mirogabalin twice daily at 12-hour intervals until POD 7 days.
Intervention Type
Drug
Intervention Name(s)
Arm II (placebo group)
Intervention Description
It is performed in the same way as Arm l.
Primary Outcome Measure Information:
Title
numeric rating scale at flexion
Description
A score of 0 indicates no pain and a score of 10 indicates maximum pain.
Time Frame
postoperative day 1
Secondary Outcome Measure Information:
Title
numeric rating scale at flexion
Description
A score of 0 indicates no pain and a score of 10 indicates maximum pain.
Time Frame
up to 3 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty American Society of Anesthesiologists class 1-3 Exclusion Criteria: Major prior ipsilateral open hip surgery Allergies to drugs used in research Difficult to manage diabetes mellitus (including insulin dependence) Chronic use of gabapentin or pregabalin (regular use for more than 3 months) Patients taking cimetidine, probenecid, or lorazepam Patients with moderate or severe hepatic impairment (AST/ALT 2.5 times or more of the upper limit of normal) Estimated glomerular filtration rate < 60 mL/min/1.73m2 Dependence on opioids In the case of subjects who cannot read the consent form (e.g. illiterate, foreigners, etc.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Do-Hyeong Kim
Phone
02-2019-3555
Email
BREADFANS@yuhs.ac
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Yeong Kim
Phone
82-2-2019-4601

12. IPD Sharing Statement

Learn more about this trial

Mirogabalin for Total Hip Arthroplasty

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