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
- Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty
- American Society of Anesthesiologists class 1-3
Exclusion Criteria
- Major prior ipsilateral open hip surgery
- Allergies to drugs used in research
- Difficult to manage diabetes mellitus (including insulin dependence)
- Chronic use of gabapentin or pregabalin (regular use for more than 3 months)
- Patients taking cimetidine, probenecid, or lorazepam
- Patients with moderate or severe hepatic impairment (AST/ALT 2.5 times or more of the upper limit of normal)
- Estimated glomerular filtration rate < 60 mL/min/1.73m2
- Dependence on opioids
- 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
Group Intervention Description mirogabalin group Arm I (mirogabalin group) perioperative mirogabalin placebo group Arm II (placebo group) placebo
- Primary Outcome Measures
Name Time Method numeric rating scale at flexion postoperative day 1 A score of 0 indicates no pain and a score of 10 indicates maximum pain.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital🇰🇷Seoul, Korea, Republic ofJi Yeong KimContact82-2-2019-4601