Mirogabalin for Total Hip Arthroplasty

Yonsei University Health System (YUHS)

Status: Enrolling

Conditions: Hip Osteoarthritis

Treatments: Drug: Arm II (placebo group); Drug: Arm I (mirogabalin group)

Study type: Interventional

Funder types: Other

Identifiers

NCT05938088

3-2023-0151

Details and patient eligibility

About

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

Enrollment: 56 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups

mirogabalin group

Experimental group

Description:

perioperative mirogabalin

Treatment:

Drug: Arm I (mirogabalin group)

placebo group

Sham Comparator group

Description:

placebo

Treatment:

Drug: Arm II (placebo group)