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IRCT20220315054298N1 IRCT 2022-04-27 Tehran University of Medical Sciences effect of ketamine on controlling pain after total knee arthroplasty comparison of the Effectiveness of pre-operative intravenous ketamine administration with placebo in controlling post-operative pain in patients with advanced knee osteoarthritis undergoing total knee arthroplasty 2022-06-01 anticipated 60 Complete https://irct.ir/trial/62552 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: block randomization will be used to produce randomized sequences .each block will consists of 4 sites including 2 placebos(B) and 2 drugs(A).That way,6 randomization pattern(permutations of 2 from 4) will be available. Random choosing of the above mentioned sites will be performed based on www.randomization.org. and will be performed Hiddenly . The placebo/drug that each patient receives will be concealed from the physician, statistician and the patient. 30 concealed envelopes that contain instructions for mixing solutions for group A, and the other 30 for group B are put on each other. content of each envelope is based on previously instructed randomization pattern. After entering the patient to the operating room ,an anesthesiology technician not involving in other part of the study will choose the first envelope from the top and follow the instructions of preparing the syringe content. He then documents the patient's ID and predetermined group. thereafter, he does not partake in any subsequent part of the study .after data gathering and completion of the analysis,the A/B labels will be decoded to prepare the final manuscript. None of the other investigators involved in patient management or data collection is aware of the group assignment, Blinding description: 60 identical sequentially numbered, opaque, sealed, and stapled envelopes(30 envelopes contain instructions for mixing solutions for group A, and the other 30 for group B) are put on each other. content of each envelope is based on previously instructed block randomization pattern. After entering the patient to the operating room ,an anesthesiology technician not involving in other part of the study will choose the first envelope from the top and follow the instructions of preparing the syringe content. The volume of each syringes will reaches 5 cc by adding normal saline so all of the injected syringes in A/B groups contains the same volume. Also, both ketamine and normal saline study solutions had the same physical properties: clear liquids with no distinctive odor .Therefore, they can not be identified or differentiated by sight or smell . The technician then documents the patient's characteristics and A/B intervention groups. The patient ,the surgeon and date collecting team members are blind of the injected liquid. After data gathering and completion of the analysis the A/B labels will be decoded to prepare the final manuscript. 2-3 Osteoarthritis of knee. Intervention 1: Intervention group: 0.5 miligram per kilogram of body weight ketamine in 5 cc syringe and increase to total volume of 5ml with normal saline. after spinal anesthesia and before incision, intravenously injected in 2 minutes. Intervention 2: Control group: 5 cc normal saline. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is data would be available on reasonable request from journal editor
public Sina Javidmehr
Shariati Hospital, Tehran
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 sinajavidmehr@gmail.com Tehran University of Medical Sciences scientific Sina Javidmehr
Shariati Hospital,Tehran
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 sinajavidmehr@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Between 18 and 85 years old undergoing unilateral, primary total knee arthroplasty "TKA" for degenerative end-stage osteoarthritis(OA) of the knee (score of >2 on Kellgren-Lawrence scale). 18 years 85 years Both patients who refuse to participate, classified as ASA IV or V by the American Society of Anesthesiologists, body mass index greater than 40 kg/m2, rheumatoid arthritis, contraindication or allergy to opioid pain medications allergy to amide or sulpha anesthetics, unable to understand the visual analog scale (VAS) , any preoperative ketamine or chronic narcotic usage (>10mg systemic morphine equivalents daily ) as it causes opioids tolerance , those who are discharged before the first 24 hours postoperatively, previous history of knee arthroplasty, prior surgery on the ipsilateral knee within 6 months, simultaneous bilateral arthroplasty, the patients receiving general anesthesia or a nerve block patients with an ejection fraction of less than 30%, creatinine clearance of less than 30mL/min, chronic liver disease, any neurologic or psychiatric disorder (including bipolar,post-traumatic stress disorder, schizophrenia), chronic alcohol abuse M17.1 Unilateral primary osteoarthritis of knee Treatment - Drugs Placebo Intervention group: 0.5 miligram per kilogram of body weight ketamine in 5 cc syringe and increase to total volume of 5ml with normal saline. after spinal anesthesia and before incision, intravenously injected in 2 minutes. Control group: 5 cc normal saline Pain. Timepoint: 2 hour , 6hour , 12 hour ,24 hour ,10 days ,42 days post operative. Method of measurement: Visual Analogue Scale. Maximum post op knee flexion. Timepoint: at discharge ,post op day 10 , post op day 42. Method of measurement: orthopedic ruler. Hospital stay duration. Timepoint: from the end of operation to discharge time. Method of measurement: time-hour. Time of first morphine request. Timepoint: from the end of operation to first time of morphine request. Method of measurement: time-hour. Total morphine(analgesics) consumption. Timepoint: at the time of discharge. Method of measurement: mg/kg....patient document. Tehran University of Medical Sciences Approved 2022-02-21 Ethics committee of Tehran University of Medical Sciences Orthopedics ward, Shariati Hospital, Jalale ale ahmad Ave., Tehran Tehran Tehran Iran (Islamic Republic of)