Clinical trial NCT05447364: Efficacy of Different Doses of Pregabalin as a Multimodal Analgesic Agent in Postoperative Pain Control After Total Knee Arthroplasty
Official title: Efficacy of Different Doses of Pregabalin as a Multimodal Analgesic Agent in Postoperative Pain Control After Total Knee Arthroplasty - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Keywords: Total Knee Arthroplasty
Pregabalin
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 82
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference on 100-mm Visual analog scale (VAS) Pain Score between 75 mg of Pregabalin and 150 mg of Pregabalin groups
timeFrame: 6, 12, 18, 24, 48 hours & 2, 6, 12 weeks after surgery
Secondary outcomes:
measure: Difference on Morphine consumption between 75 mg of Pregabalin and 150 mg of Pregabalin groups
timeFrame: From postoperative period until 48 hours after surgery
measure: Difference on side effects between 75 mg of Pregabalin and 150 mg of Pregabalin groups
timeFrame: 6, 12, 18, 24, 48 hours & 2, 6, 12 weeks after surgery
measure: Difference on length of stay between 75 mg of Pregabalin and 150 mg of Pregabalin groups
timeFrame: From postoperative period until 48 hours after surgery
measure: Difference on time to ambulation between 75 mg of Pregabalin and 150 mg of Pregabalin groups
timeFrame: From postoperative period until 48 hours after surgery
measure: Difference on Range of motion between 75 mg of Pregabalin and 150 mg of Pregabalin groups
timeFrame: 2, 6, 12 weeks after surgery
measure: Difference on Knee Society Score between 75 mg of Pregabalin and 150 mg of Pregabalin groups
timeFrame: 2, 6, 12 weeks after surgery
measure: Difference on Knee injury and Osteoarthritis Outcome Score between 75 mg of Pregabalin and 150 mg of Pregabalin groups
timeFrame: 2, 6, 12 weeks after surgery
measure: Difference on Time up-and-go test between between 75 mg of Pregabalin and 150 mg of Pregabalin groups
timeFrame: 2, 6, 12 weeks after surgery
measure: Difference on 2-minutes walking test between 75 mg of Pregabalin and 150 mg of Pregabalin groups
timeFrame: 2, 6, 12 weeks after surgery
Other outcomes:
Locations:
city: Pathum Thani
country: Thailand
facility: Thammasat University Hospital
state: Pathumthani
Study officials:
References:
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.