Hip Osteoarthritis
Conditions
Brief summary
The purpose of this study is to confirm the analgesic effect of mirogabalin in patients undergoing unilateral hip arthroplasty.
Interventions
DRUGArm 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.
DRUGArm II (placebo group)
It is performed in the same way as Arm l.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| numeric rating scale at flexion | postoperative day 1 | A score of 0 indicates no pain and a score of 10 indicates maximum pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Contacts
Primary ContactDo-Hyeong Kim
Outcome results
None listed