Comparing Efficiency of Mirogabalin and Pregabalin in Primary TKA
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorThammasat University Hospital
About this trial
The goal of this RCT is to compare efficacy between mirogabalin and pregabalin in pain reducing after unilateral primary total knee arthroplasty.
The main question\[s\] it aims to answer are:
• Does mirogabalin have better pain reduction than pregabalin after unilateral primary total knee arthroplasty.
Participants will randomized to mirogabalin or pregabalin group and will take the drug for 2 weeks after TKA. Researchers will compare to pregabalin group to see pain and functional outcomes after TKA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 50-85 years old
Unilateral primary osteoarthritis undergoing primary TKA
ASA I-III
Disqualifiers
GFR <60
Allergy to drug in this study
Cannot underwent spinal anesthesia and adductor canal block
Taking gabapentinoid within 3 months before surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Mirogabalin
DrugParticipants will receive 5 mg of mirogabalin, twice a day, after breakfast and dinner, for 2 weeks.
Pregabalin
DrugParticipants will receive 75 mg of pregabalin, once a day before bedtime, for 2 weeks.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: MirogabalinExperimental treatment 1 intervention
Group B: PregabalinActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain score
Visual analog scale at rest and motion (0-100 points, 0 mean best, 100 mean worst)
Time frame
Every 6 hours after surgery for 2 days, then twice a day for 2 weeks, then once a week until 12 week after surgery.Secondary outcomes
1
Morphine consumption
Total morphine consumption in hospital (mg)
Time frame
72 hours after surgery2
Range of motion
Using long arm goniometer (degrees)
Time frame
24 hour, 48 hour, 2 week, 6 week and 12 week after surgery3
Knee society score
report in point (0-100, 0 mean worst, 100 mean best)
Time frame
2 week, 6 week and 12 week after surgery4
Knee injury and Osteoarthritis Outcome Score (KOOS)
report in point (0-100, 0 mean worst, 100 mean best)
Time frame
2 week, 6 week and 12 week after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov