Efficacy of Different Doses of Pregabalin as a Multimodal Analgesic Agent in Postoperative Pain Control After Total Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Different Doses of Pregabalin as a Multimodal Analgesic Agent in Postoperative Pain Control After Total Knee Arthroplasty - A Randomized Controlled Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Drug: Pregabalin 75mg
* Drug: Pregabalin 150mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic primary knee osteoarthritis undergoing unilateral TKA Aged between 55 and 80 years old Comply with protocol Exclusion Criteria: Allergy to any of the medications in this protocol (Pregabalin, Morphine, Paracetamol, Celecoxib, Tramadol, Aspirin) Secondary osteoarthritis of the knee including autoimmune diseases and post-traumatic Previous surgery on the knee Contraindicated to spinal anesthesia (SB) or Adductor canal block (ACB) GFR < 30ml/min, Severe Liver Function (Child-Pugh C) History of seizure or cerebrovascular diseases

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 75 mg of Pregabalin<br>Participant received 1 tab of 75 mg of Pregabalin and 1 tab of placebo | Drug: Pregabalin 75mg<br>* 1 tab of Pregabalin Brillior 75 mg and 1 tab of Placebo<br>|
| Active Comparator: 150 mg of Pregabalin<br>Participant received 2 tabs of 75 mg of Pregabalin | Drug: Pregabalin 150mg<br>* 2 tabs of Pregabalin Brillior 75 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference on 100-mm Visual analog scale (VAS) Pain Score between 75 mg of Pregabalin and 150 mg of Pregabalin groups | 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 | 6, 12, 18, 24, 48 hours & 2, 6, 12 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference on Morphine consumption between 75 mg of Pregabalin and 150 mg of Pregabalin groups | Amount of Morphine consumption as rescue pain control reported as mg per day | From postoperative period until 48 hours after surgery | 
| Difference on side effects between 75 mg of Pregabalin and 150 mg of Pregabalin groups | Common of side effects of Pregabalin and Morphine including sedation, dizziness, visual disturbances, nausea and vomiting | 6, 12, 18, 24, 48 hours & 2, 6, 12 weeks after surgery | 
| Difference on length of stay between 75 mg of Pregabalin and 150 mg of Pregabalin groups | Time to discharge | From postoperative period until 48 hours after surgery | 
| Difference on time to ambulation between 75 mg of Pregabalin and 150 mg of Pregabalin groups | Time from operation to ambulation before hospital discharge | From postoperative period until 48 hours after surgery | 
| Difference on Range of motion between 75 mg of Pregabalin and 150 mg of Pregabalin groups | - Flexion and extension angle of the knee is measured by a long-arm goniometer | 2, 6, 12 weeks after surgery | 
| Difference on Knee Society Score between 75 mg of Pregabalin and 150 mg of Pregabalin groups | 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 | 2, 6, 12 weeks after surgery | 
| Difference on Knee injury and Osteoarthritis Outcome Score between 75 mg of Pregabalin and 150 mg of Pregabalin groups | 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 | 2, 6, 12 weeks after surgery | 
| Difference on Time up-and-go test between between 75 mg of Pregabalin and 150 mg of Pregabalin groups | 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. | 2, 6, 12 weeks after surgery | 
| Difference on 2-minutes walking test between 75 mg of Pregabalin and 150 mg of Pregabalin groups | 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. | 2, 6, 12 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty, Pregabalin