Clinical trial NCT06328062: Comparing Efficiency of Mirogabalin and Pregabalin in Primary TKA
Official title: Comparison Efficacy of Mirogabalin and Pregabalin in Total Knee Arthroplasty. a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain Postoperative
Osteoarthritis
Total Knee Arthroplasty
Keywords: mirogabalin
pregabalin
pain postoperative
TKA
Lead sponsor: Thammasat University Hospital
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 6 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, taken as half a tablet, every day.

Twice a day, after breakfast and dinner, for 6 weeks. In the pregabalin group: Participants received 50 mg of pregabalin, one tablet taken daily.

Twice a day, after breakfast and dinner, for 6 weeks

Eligibility criteria: Inclusion Criteria:

1. Age 50-85 years old
2. Unilateral primary osteoarthritis undergoing primary TKA
3. ASA I-III

Exclusion Criteria:

1. GFR \&lt;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

Primary outcomes:
measure: Pain score
timeFrame: 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:
measure: Morphine consumption
timeFrame: 72 hours after surgery
measure: Range of motion
timeFrame: 24 hour, 48 hour, 2 week, 6 week and 12 week after surgery
measure: Knee society score
timeFrame: 2 week, 6 week and 12 week after surgery
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 2 week, 6 week and 12 week after surgery
measure: Sedation score
timeFrame: 24 hour, 48 hour, 2 week, 6 week and 12 week after surgery
measure: Incidence of Somnolence and dizziness
timeFrame: everyday until 14 days then once a week until 12 weeks after surgery
measure: Total hospital stay
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Khlong Luang
country: Thailand
facility: Thammasat University Hospital
state: Pathum Thani
Study officials:
References:
citation: Hannon CP, Fillingham YA, Browne JA, Schemitsch EH, Mullen K, Casambre F, Visvabharathy V, Hamilton WG, Della Valle CJ. The Efficacy and Safety of Gabapentinoids in Total Joint Arthroplasty: Systematic Review and Direct Meta-Analysis. J Arthroplasty. 2020 Oct;35(10):2730-2738.e6. doi: 10.1016/j.arth.2020.05.033. Epub 2020 May 26.
citation: Kim JY, Abdi S, Huh B, Kim KH. Mirogabalin: could it be the next generation gabapentin or pregabalin? Korean J Pain. 2021 Jan 1;34(1):4-18. doi: 10.3344/kjp.2021.34.1.4.