The Efficacy and Safety of Gabapentinoids in Total Joint Arthroplasty: Systematic Review and Direct Meta-Analysis.
Charles P Hannon, Yale A Fillingham, James A Browne...
https://pubmed.ncbi.nlm.nih.gov/32586656Actively Recruiting
Phase Not Applicable
Age: 50Years - 85Years
All Genders
ID06328062
Comparison Efficacy of Mirogabalin and Pregabalin in Total Knee Arthroplasty A Randomized Controlled Trial
Led by Thammasat University Hospital · Updated on 2025-04-09
80
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
This trial investigates pain management after unilateral primary total knee arthroplasty (TKA) by comparing two drugs, mirogabalin and pregabalin. The study aims to determine whether mirogabalin provides better pain relief than pregabalin in patients aged 50 to 85 years undergoing TKA. This research helps understand the effectiveness of these medications for postoperative pain and functional recovery. After surgery, participants are randomly assigned to receive either mirogabalin or pregabalin along with other standard treatments. Those in the mirogabalin group take 5 mg twice daily, half a tablet after breakfast and dinner, for 6 weeks. Participants in the pregabalin group take 50 mg twice daily, one tablet after breakfast and dinner, also for 6 weeks. Participants will be monitored closely with pain scores recorded every 6 hours for 2 days, then twice daily for 2 weeks, and weekly until 12 weeks after surgery. Other assessments include morphine use, knee range of motion, knee function scores, sedation levels, dizziness and sleepiness incidence, and hospital stay duration. These evaluations help researchers compare pain relief and recovery progress between treatments over 12 weeks.
CONDITIONS
Brief Title
Comparing Efficiency of Mirogabalin and Pregabalin in Primary TKA
Who Can Participate
Age: 50Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 50-85 years old
- Diagnosis of unilateral primary osteoarthritis scheduled for primary total knee arthroplasty
- American Society of Anesthesiologists (ASA) physical status classification I to III
You will not qualify if you...
- Glomerular filtration rate (GFR) less than 60
- Allergy to either study drug
- Unable to undergo spinal anesthesia and adductor canal block
- Use of gabapentinoid medication within 3 months before surgery
- History of previous knee surgery
- Severe liver disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Up to 1 week
Participants undergo total knee arthroplasty surgery followed by immediate post-operative care.
Hospital stay up to 1 week
Treatment
Duration - 6 weeks
After surgery, participants receive either Mirogabalin or Pregabalin twice daily along with other standard medications for pain management.
Daily medication taken twice a day
Follow-up
Duration - Up to 12 weeks after surgery
Participants are monitored for pain, medication side effects, and functional recovery through scheduled assessments after treatment ends.
Frequent assessments: every 6 hours for 2 days, twice daily for 2 weeks, then weekly visits up to 12 weeks
Trial Site Locations
Total: 1 location
1
Thammasat University Hospital
Khlong Luang, Changwat Pathum Thani, Thailand, 12120
Actively Recruiting
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Research Team
Y
Yot Tanariyakul, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Mirogabalin: could it be the next generation gabapentin or pregabalin?
Jae-Yeon Kim, Salahadin Abdi, Billy Huh...
https://pubmed.ncbi.nlm.nih.gov/33380563