Mirogabalin for Total Hip Arthroplasty

Sponsor

Gangnam Severance Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05938088

Collaborator

(none)

Enrollment

Arms

23.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hip Osteoarthritis	Drug: Arm I (mirogabalin group) Drug: Arm II (placebo group)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Mirogabalin and Pain After Total Hip Arthroplasty: a Double-blind, Randomized, Placebo-controlled Trial

Anticipated Study Start Date :

Jul 15, 2023

Anticipated Primary Completion Date :

Jun 28, 2025

Anticipated Study Completion Date :

Jun 28, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mirogabalin group perioperative mirogabalin	Drug: Arm I (mirogabalin group) 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.
Sham Comparator: placebo group placebo	Drug: Arm II (placebo group) It is performed in the same way as Arm l.

Arm

Intervention/Treatment

Experimental: mirogabalin group

perioperative mirogabalin

Drug: Arm I (mirogabalin group)

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.

Sham Comparator: placebo group

placebo

Drug: Arm II (placebo group)

It is performed in the same way as Arm l.

Outcome Measures

Primary Outcome Measures

numeric rating scale at flexion [postoperative day 1]
A score of 0 indicates no pain and a score of 10 indicates maximum pain.

Secondary Outcome Measures

numeric rating scale at flexion [up to 3 month after surgery]
A score of 0 indicates no pain and a score of 10 indicates maximum pain.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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.)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Do-Hyeong Kim, Associate Professor, Gangnam Severance Hospital

ClinicalTrials.gov Identifier:

NCT05938088

Other Study ID Numbers:

3-2023-0151

First Posted:

Jul 10, 2023

Last Update Posted:

Jul 11, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoarthritis, Hip

Study Results

No Results Posted as of Jul 11, 2023