Mirogabalin for Total Hip Arthroplasty

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05938088
• Other study ID #: 3-2023-0151
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2023
• Est. completion date: June 28, 2025

Study information

• Verified date: August 2023
• Source: Gangnam Severance Hospital
• Contact: Do-Hyeong Kim
• Phone: 02-2019-3555
• Email: BREADFANS[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: June 28, 2025
• Est. primary completion date: June 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty

2. American Society of Anesthesiologists class 1-3

Exclusion Criteria:

1. Major prior ipsilateral open hip surgery

2. Allergies to drugs used in research

3. Difficult to manage diabetes mellitus (including insulin dependence)

4. Chronic use of gabapentin or pregabalin (regular use for more than 3 months)

5. Patients taking cimetidine, probenecid, or lorazepam

6. Patients with moderate or severe hepatic impairment (AST/ALT 2.5 times or more of the upper limit of normal)

7. Estimated glomerular filtration rate < 60 mL/min/1.73m2

8. Dependence on opioids

9. In the case of subjects who cannot read the consent form (e.g. illiterate, foreigners, etc.)

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

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.
• Arm II (placebo group)
It is performed in the same way as Arm l.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	numeric rating scale at flexion	A score of 0 indicates no pain and a score of 10 indicates maximum pain.	postoperative day 1
Secondary	numeric rating scale at flexion	A score of 0 indicates no pain and a score of 10 indicates maximum pain.	up to 3 month after surgery