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Mirogabalin for Total Hip Arthroplasty

Not Applicable
Recruiting
Conditions
Hip Osteoarthritis
Interventions
Drug: Arm I (mirogabalin group)
Drug: Arm II (placebo group)
Registration Number
NCT05938088
Lead Sponsor
Gangnam Severance Hospital
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
56
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.)

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
mirogabalin groupArm I (mirogabalin group)perioperative mirogabalin
placebo groupArm II (placebo group)placebo
Primary Outcome Measures
NameTimeMethod
numeric rating scale at flexionpostoperative day 1

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

Secondary Outcome Measures
NameTimeMethod
numeric rating scale at flexionup to 3 month after surgery

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

Trial Locations

Locations (1)

Gangnam Severance Hospital

🇰🇷

Seoul, Korea, Republic of

Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Ji Yeong Kim
Contact
82-2-2019-4601
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