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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirogabalin | Experimental | Participants will receive 5 mg of mirogabalin, taken as half a tablet, every day twice a day, after breakfast and dinner, for 6 weeks. |
|
| Pregabalin | Active Comparator | Participants will receive 50 mg of pregabalin, taken as a tablet, every day twice a day, after breakfast and dinner, for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirogabalin | Drug | Participants will receive 5 mg of mirogabalin, taken as half a tablet, every day twice a day, after breakfast and dinner, for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Visual analog scale at rest and motion (0-100 points, 0 mean best, 100 mean worst) | Every 6 hours after surgery for 2 days, then twice a day for 2 weeks, then once a week until 12 week after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption | Total morphine consumption in hospital (mg) | 72 hours after surgery |
| Range of motion | Using long arm goniometer (degrees) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yot Tanariyakul, M.D. | Contact | +66863930257 | y.tanariyakul@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thammasat University Hospital | Recruiting | Khlong Luang | Changwat Pathum Thani | 12120 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32586656 | Result | 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. | |
| 33380563 |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C000598618 | mirogabalin |
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Pregabalin | Drug | Participants will receive 50 mg of pregabalin, taken as a tablet, every day twice a day, after breakfast and dinner, for 6 weeks. |
|
| 24 hour, 48 hour, 2 week, 6 week and 12 week after surgery |
| Knee society score | report in point (0-100, 0 mean worst, 100 mean best) | 2 week, 6 week and 12 week after surgery |
| Knee injury and Osteoarthritis Outcome Score (KOOS) | report in point (0-100, 0 mean worst, 100 mean best) | 2 week, 6 week and 12 week after surgery |
| Sedation score | report in point (0-100, 0 mean best, 100 mean worst) | 24 hour, 48 hour, 2 week, 6 week and 12 week after surgery |
| Incidence of Somnolence and dizziness | Using scale "Mild, moderate and severe" | everyday until 14 days then once a week until 12 weeks after surgery |
| Total hospital stay | Number of days the patient stays for surgery | up to 1 week |
| 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |