Mirogabalin for Total Hip Arthroplasty

NCT05938088 | Unknown

• 1 other identifier: 3-2023-0151
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• numeric rating scale at flexion

  A score of 0 indicates no pain and a score of 10 indicates maximum pain.

  postoperative day 1

Secondary Outcomes (1)

• numeric rating scale at flexion

  up to 3 month after surgery

Study Arms (2)

mirogabalin group

EXPERIMENTAL

perioperative mirogabalin

Drug: Arm I (mirogabalin group)

placebo group

SHAM COMPARATOR

placebo

Drug: Arm II (placebo group)

Interventions

Arm I (mirogabalin group) DRUG

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.

mirogabalin group

Arm II (placebo group) DRUG

It is performed in the same way as Arm l.

placebo group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty
• American Society of Anesthesiologists class 1-3

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Do-Hyeong Kim

CONTACT

02-2019-3555; BREADFANS@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 10, 2023
• Study Start: July 20, 2023
• Primary Completion: June 28, 2025
• Study Completion: June 28, 2025
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

KR (1)