Using mirogabalin to manage pain after hip surgery

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

This study is testing whether mirogabalin can help reduce pain after hip surgery for people with hip osteoarthritis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Gangnam Severance Hospital (Academic / other)
• Locations: 1 site (Seoul)
• Trial ID: NCT05938088 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of mirogabalin in reducing pain for patients undergoing unilateral hip arthroplasty due to hip osteoarthritis. Participants will be randomly assigned to receive either mirogabalin or a placebo to assess the analgesic effects of the medication post-surgery. The study will include patients aged 19 and older who meet specific health criteria, ensuring a focused evaluation of mirogabalin's benefits in this surgical context.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 and older scheduled for unilateral hip arthroplasty.

Not a fit: Patients with significant prior hip surgeries, severe diabetes, or those on certain medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new pain management option for patients recovering from hip arthroplasty.

How similar studies have performed: While the specific use of mirogabalin in this context may be novel, similar studies evaluating pain management strategies post-surgery have shown promising results.

Eligibility criteria

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.)

Where this trial is running

Seoul

• Gangnam Severance Hospital — Seoul, Korea, Republic of (Recruiting)

Study contacts

• Study coordinator: Do-Hyeong Kim

Conditions Hip Osteoarthritis