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IRCT2016073129132N2 IRCT 2016-08-24 Isfahan University of Medical Sciences and Health Cares. Preventive injection of some types of pain-relief drugs around knee joint for management of pain after complete replacement of knee joint. TKA: Total knee arthroplasty, KSS: Knee Society Score, VAS: Visual Analog Scale. Preemptive Injection of Periarticular-Multimodal Drug for Postoperative Pain Management in Total Knee Arthroplasty: A double-blind randomized clinical trial. 2014-11-01 anticipated 120 Complete https://irct.ir/trial/23497 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Condition 1: Arthrosis of knee (Gonarthrosis). Condition 2: Severity of pain after Total Knee Arthroplasty. Condition 3: Total Knee Arthroplasty. Intervention 1: Intervention group: Intervention Name: Preemptive Injection of Periarticular-Multimodal Drug Intervention Description:Injection of a cocktail including Bupivacaine hydrochloride 0.5% (AstraZeneca, Cenexi, France) 50 mg, Morphine sulfate10 mg (Darou Pakhsh, Tehran, Iran), Epinephrin (1:1000) (Darou Pakhsh, Tehran, Iran) 300 mcg and ketorolac (Caspian Tamin, Rasht, Iran) 30 mg which are all diluted by 0.9 % sodium chloride solution to make a total of 100 ml (15 minutes before surgery). Intervention 2: Control group: Intervention name: Routinely preemptive Injection Intervention discription: Preemptive Injection of Epinephrine (1:1000) that also been diluted in 0.9 % sodium chloride to make a total of 100 ml (15 minutes before surgery).
public Sajad Badiei
Unit 4, NO 73, Ariya ِDead, Shahid Soltani Alley, Shah Seyed Ali Alley, Abulhasan Isfahani Boulevard.
Isfahan Iran (Islamic Republic of) 8153976191 +98 31 3264 4568 s_badiei@edc.mui.ac.ir Isfahan University of Medical Sciences scientific Sajad Badiei
Unit 4, NO 73, Ariya Dead, Shahid Soltani Alley, Shah Seyed Ali Alley, Abulhasan Isfahani Boulevard.
Isfahan Iran (Islamic Republic of) 8153976191 +98 31 3264 4568 s_badiei@edc.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: individuals with osteoarthritis who were scheduled for primary unilateral TKA. Exclusion criteria: BMI greater than 40; previous history of allergy to any medications; known abuser of alcohol and other drugs; any inflammatory arthritis; previous major surgery in the same knee joint indicated for TKA; individuals who were candidated for bilateral TKA; patients who did not show up for the follow-up. 30 years 80 years Both M17.1 T84.8 Z96.8 Other primary gonarthrosis Other complications of internal orthopaedic prosthetic devices, implants and grafts Presence of other specified functional implants Treatment - Drugs Treatment - Drugs Intervention group: Intervention Name: Preemptive Injection of Periarticular-Multimodal Drug Intervention Description:Injection of a cocktail including Bupivacaine hydrochloride 0.5% (AstraZeneca, Cenexi, France) 50 mg, Morphine sulfate10 mg (Darou Pakhsh, Tehran, Iran), Epinephrin (1:1000) (Darou Pakhsh, Tehran, Iran) 300 mcg and ketorolac (Caspian Tamin, Rasht, Iran) 30 mg which are all diluted by 0.9 % sodium chloride solution to make a total of 100 ml (15 minutes before surgery). Control group: Intervention name: Routinely preemptive Injection Intervention discription: Preemptive Injection of Epinephrine (1:1000) that also been diluted in 0.9 % sodium chloride to make a total of 100 ml (15 minutes before surgery). The severity of the pain in knee joint. Timepoint: 24 hours, 48 hours and 6 weeks after the surgery. Method of measurement: Visual Analog Scale (VAS). Function of knee joint. Timepoint: 6 weeks and 6 months after surgery. Method of measurement: Knee Society Score. Isfahan University of Medical Sciences and Health Cares. Approved 2014-10-21 Isfahan University of Medical Sciences Hezarjarib St. Isfahan Iran (Islamic Republic of)