Osteoarthritis, Pain Postoperative, Total Knee Arthroplasty
Conditions
Keywords
mirogabalin, pregabalin, pain postoperative, TKA
Brief summary
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.
Detailed description
After surgery is complete, you will be randomly assigned to receive painkillers Mirogabalin or Pregabalin along with other standard medications. Surgery by Mirogabalin group: Participants received 5 mg of mirogabalin, one tablet taken twice a day, after breakfast and dinner, for 2 weeks. In the pregabalin group: Participants received 75 mg of pregabalin, one tablet taken daily before bedtime, for 2 weeks.
Interventions
DRUGMirogabalin
Participants will receive 5 mg of mirogabalin, twice a day, after breakfast and dinner, for 2 weeks.
DRUGPregabalin
Participants will receive 75 mg of pregabalin, once a day before bedtime, for 2 weeks.
Sponsors
Thammasat University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age 50-85 years old 2. Unilateral primary osteoarthritis undergoing primary TKA 3. ASA I-III
Exclusion criteria
1. GFR \<60 2. Allergy to drug in this study 3. Cannot underwent spinal anesthesia and adductor canal block 4. Taking gabapentinoid within 3 months before surgery 5. History of previous knee surgery 6. Severe liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | Every 6 hours after surgery for 2 days, then twice a day for 2 weeks, then once a week until 12 week after surgery. | Visual analog scale at rest and motion (0-100 points, 0 mean best, 100 mean worst) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morphine consumption | 72 hours after surgery | Total morphine consumption in hospital (mg) |
| Range of motion | 24 hour, 48 hour, 2 week, 6 week and 12 week after surgery | Using long arm goniometer (degrees) |
| Knee society score | 2 week, 6 week and 12 week after surgery | report in point (0-100, 0 mean worst, 100 mean best) |
| Knee injury and Osteoarthritis Outcome Score (KOOS) | 2 week, 6 week and 12 week after surgery | report in point (0-100, 0 mean worst, 100 mean best) |
| Sedation score | 24 hour, 48 hour, 2 week, 6 week and 12 week after surgery | report in point (0-100, 0 mean best, 100 mean worst) |
| Incidence of Somnolence and dizziness | everyday until 14 days then once a week until 12 weeks after surgery | Using scale "Mild, moderate and severe" |
| Total hospital stay | up to 1 week | Number of days the patient stays for surgery |
Countries
Thailand
Contacts
CONTACTYot Tanariyakul, M.D.
Outcome results
None listed