Knee Osteoarthritis
Conditions
Keywords
Total Knee Arthroplasty, Pregabalin
Brief summary
The purpose of this study is to compare the efficacy of 75 mg of Pregabalin and 150 mg of Pregabalin in postoperative pain control after TKA.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will be chosen for eligibility for the study entry. At the day before surgery date, patients who meet the eligibility criteria will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to 75 mg of Pregabalin and 150 mg of Pregabalin groups.
Interventions
DRUGPregabalin 75mg
1 tab of Pregabalin Brillior 75 mg and 1 tab of Placebo
DRUGPregabalin 150mg
2 tabs of Pregabalin Brillior 75 mg
Sponsors
Thammasat University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Participants are randomized and assigned to 75 mg of Pregabalin and 150 of Pregabalin groups in parallel for the duration of the study
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Symptomatic primary knee osteoarthritis undergoing unilateral TKA 2. Aged between 55 and 80 years old 3. Comply with protocol
Exclusion criteria
1. Allergy to any of the medications in this protocol (Pregabalin, Morphine, Paracetamol, Celecoxib, Tramadol, Aspirin) 2. Secondary osteoarthritis of the knee including autoimmune diseases and post-traumatic 3. Previous surgery on the knee 4. Contraindicated to spinal anesthesia (SB) or Adductor canal block (ACB) 5. GFR \< 30ml/min, Severe Liver Function (Child-Pugh C) 6. History of seizure or cerebrovascular diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference on 100-mm Visual analog scale (VAS) Pain Score between 75 mg of Pregabalin and 150 mg of Pregabalin groups | 6, 12, 18, 24, 48 hours & 2, 6, 12 weeks after surgery | * The 100-mm VAS pain score is a self-reported instrument assessing pain scores. * Participants will assess the VAS pain score at rest and on-movement * VAS Pain at rest is evaluated when the participant is at rest. * VAS Pain on-movement is evaluated on active extension and flexion of the operated knee using mean scores between the two. * Possible scores range from 0 (no pain) to 100 (worst imaginable pain) * Higher scores mean a worse pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference on side effects between 75 mg of Pregabalin and 150 mg of Pregabalin groups | 6, 12, 18, 24, 48 hours & 2, 6, 12 weeks after surgery | Common of side effects of Pregabalin and Morphine including sedation, dizziness, visual disturbances, nausea and vomiting |
| Difference on length of stay between 75 mg of Pregabalin and 150 mg of Pregabalin groups | From postoperative period until 48 hours after surgery | Time to discharge |
| Difference on time to ambulation between 75 mg of Pregabalin and 150 mg of Pregabalin groups | From postoperative period until 48 hours after surgery | Time from operation to ambulation before hospital discharge |
| Difference on Range of motion between 75 mg of Pregabalin and 150 mg of Pregabalin groups | 2, 6, 12 weeks after surgery | \- Flexion and extension angle of the knee is measured by a long-arm goniometer |
| Difference on Morphine consumption between 75 mg of Pregabalin and 150 mg of Pregabalin groups | From postoperative period until 48 hours after surgery | Amount of Morphine consumption as rescue pain control reported as mg per day |
| Difference on Knee injury and Osteoarthritis Outcome Score between 75 mg of Pregabalin and 150 mg of Pregabalin groups | 2, 6, 12 weeks after surgery | * The Knee injury and Osteoarthritis Outcome Score is a validated, patient reported joint-specific score to assess patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items) * The Knee injury and Osteoarthritis Outcome Score range from 0 to 100 * Higher scores on the Knee injury and Osteoarthritis Outcome Score indicate better knee conditions |
| Difference on Time up-and-go test between between 75 mg of Pregabalin and 150 mg of Pregabalin groups | 2, 6, 12 weeks after surgery | * The Time up-and-go test (TUGT) measures the time (seconds) that the patient takes to rise from a chair and walk for 3 meters. Then, he or she turns around and comes back to the seat at the initial position. * They were permitted to use walking aids if they wished. * TUGT was a reliable and valid test for quantifying functional mobility. |
| Difference on 2-minutes walking test between 75 mg of Pregabalin and 150 mg of Pregabalin groups | 2, 6, 12 weeks after surgery | * Participants were instructed to walk for 2 minutes at their normal pace up and down a designated corridor, turning around at each end of the corridor without stopping * They were permitted to use walking aids if they wished. * The results were recorded as the total distance walked in meters. |
| Difference on Knee Society Score between 75 mg of Pregabalin and 150 mg of Pregabalin groups | 2, 6, 12 weeks after surgery | * The Knee Society Score is a validated, objective scoring system to evaluate patient's functional abilities before and after total knee arthroplasty * The Knee Society Score has 2 sections including Knee Score and Functional Score with both sections scored from 0 to 100 * Higher scores on the Knee Society Score indicate better knee conditions |
Countries
Thailand
Outcome results
None listed