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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 75 mg of Pregabalin | Experimental | Participant received 1 tab of 75 mg of Pregabalin and 1 tab of placebo |
|
| 150 mg of Pregabalin | Active Comparator | Participant received 2 tabs of 75 mg of Pregabalin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin 75mg | Drug | 1 tab of Pregabalin Brillior 75 mg and 1 tab of Placebo |
| |
| 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 |
| 6, 12, 18, 24, 48 hours & 2, 6, 12 weeks after surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thammasat University Hospital | Pathum Thani | Changwat Pathum Thani | 12120 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25209095 | Result | Mishriky BM, Waldron NH, Habib AS. Impact of pregabalin on acute and persistent postoperative pain: a systematic review and meta-analysis. Br J Anaesth. 2015 Jan;114(1):10-31. doi: 10.1093/bja/aeu293. Epub 2014 Sep 10. | |
| 28705543 | Result | Golladay GJ, Balch KR, Dalury DF, Satpathy J, Jiranek WA. Oral Multimodal Analgesia for Total Joint Arthroplasty. J Arthroplasty. 2017 Sep;32(9S):S69-S73. doi: 10.1016/j.arth.2017.05.002. Epub 2017 May 11. |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Beginning 3 months and ending 5 years following article publication.
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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Participants are randomized and assigned to 75 mg of Pregabalin and 150 of Pregabalin groups in parallel for the duration of the study
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| Pregabalin 150mg |
| Drug |
2 tabs of Pregabalin Brillior 75 mg |
|
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 |
| 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 |
| 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 |
| 2, 6, 12 weeks after surgery |
| Difference on 2-minutes walking test between 75 mg of Pregabalin and 150 mg of Pregabalin groups |
| 2, 6, 12 weeks after surgery |
| 24051389 | Result | Schmidt PC, Ruchelli G, Mackey SC, Carroll IR. Perioperative gabapentinoids: choice of agent, dose, timing, and effects on chronic postsurgical pain. Anesthesiology. 2013 Nov;119(5):1215-21. doi: 10.1097/ALN.0b013e3182a9a896. No abstract available. |
| 31985507 | Result | Summers S, Mohile N, McNamara C, Osman B, Gebhard R, Hernandez VH. Analgesia in Total Knee Arthroplasty: Current Pain Control Modalities and Outcomes. J Bone Joint Surg Am. 2020 Apr 15;102(8):719-727. doi: 10.2106/JBJS.19.01035. No abstract available. |
| 19910619 | Result | Buvanendran A, Kroin JS, Della Valle CJ, Kari M, Moric M, Tuman KJ. Perioperative oral pregabalin reduces chronic pain after total knee arthroplasty: a prospective, randomized, controlled trial. Anesth Analg. 2010 Jan 1;110(1):199-207. doi: 10.1213/ANE.0b013e3181c4273a. Epub 2009 Nov 12. |
| 18716003 | Result | Agarwal A, Gautam S, Gupta D, Agarwal S, Singh PK, Singh U. Evaluation of a single preoperative dose of pregabalin for attenuation of postoperative pain after laparoscopic cholecystectomy. Br J Anaesth. 2008 Nov;101(5):700-4. doi: 10.1093/bja/aen244. Epub 2008 Aug 20. |
| 23325966 | Result | Jain P, Jolly A, Bholla V, Adatia S, Sood J. Evaluation of efficacy of oral pregabalin in reducing postoperative pain in patients undergoing total knee arthroplasty. Indian J Orthop. 2012 Nov;46(6):646-52. doi: 10.4103/0019-5413.104196. |
| 31733981 | Result | Azboy I, Groff H, Goswami K, Vahedian M, Parvizi J. Low-Dose Aspirin Is Adequate for Venous Thromboembolism Prevention Following Total Joint Arthroplasty: A Systematic Review. J Arthroplasty. 2020 Mar;35(3):886-892. doi: 10.1016/j.arth.2019.09.043. Epub 2019 Oct 5. |
| 24630598 | Result | Noiseux NO, Callaghan JJ, Clark CR, Zimmerman MB, Sluka KA, Rakel BA. Preoperative predictors of pain following total knee arthroplasty. J Arthroplasty. 2014 Jul;29(7):1383-7. doi: 10.1016/j.arth.2014.01.034. Epub 2014 Feb 7. |
| 29454556 | Result | Unnanuntana A, Ruangsomboon P, Keesukpunt W. Validity and Responsiveness of the Two-Minute Walk Test for Measuring Functional Recovery After Total Knee Arthroplasty. J Arthroplasty. 2018 Jun;33(6):1737-1744. doi: 10.1016/j.arth.2018.01.015. Epub 2018 Jan 31. |
| 26170351 | Result | YaDeau JT, Lin Y, Mayman DJ, Goytizolo EA, Alexiades MM, Padgett DE, Kahn RL, Jules-Elysee KM, Ranawat AS, Bhagat DD, Fields KG, Goon AK, Curren J, Westrich GH. Pregabalin and pain after total knee arthroplasty: a double-blind, randomized, placebo-controlled, multidose trial. Br J Anaesth. 2015 Aug;115(2):285-93. doi: 10.1093/bja/aev217. |
| D012216 |
| Rheumatic Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |