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IRCT20170516033992N12 IRCT 2022-11-29 Oroumia University of Medical Sciences Studying the intravenous lidocaine infusion effect on pain Studying the intravenous lidocaine infusion effect on pain in patients undergoing femoral neck fracture surgery 2022-12-22 anticipated 64 Complete https://irct.ir/trial/66815 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into intervention or placebo groups using the block randomization method based on generated numbers by Random allocation software. Thus, in this software, first, the number of groups and the total determined sample size will be entered, and then in the block section, the Block randomization method will be implemented. According to the total sample size (64 patients), 16 blocks of 4 will be used. Patients will be allocated to intervention or placebo groups based on generated numbers, Blinding description: The study will be conducted as a double-blind clinical trial. The patient and the researcher evaluating the outcomes will be blind to the allocation of patients into intervention or placebo groups. Syringes containing drug and placebo will be similar in shape and size and the drug will be prescribed by an anesthesiologist (other than the outcome assessor). so, the table of computer-generated numbers will be given to the anesthesiologist. The anesthesiologist will enter the patients into groups according to the order of numbers. Finally, the name of groups will be encoded with the letters A and B. 3 Fracture of neck of femur. Intervention 1: Intervention group: First, all patients will receive intravenous midazolam (0.05 mg/kg) and intravenous fentanyl (2 μg/kg) as premedication. 5 minutes later, propofol 2 mg/kg and atracurium 0.5 mg/kg will be injected. 10 minutes before the surgery, in the intervention group; firstly, 1.5 mg/kg intravenously of lidocaine solution 1% will be injected; then the infusion of lidocaine 1% with a dose of 2 mg/kg per hour will be started with a syringe pump infusion device. Intervention 2: Control group: First, all patients will receive intravenous midazolam (0.05 mg/kg) and intravenous fentanyl (2 μg/kg) as premedication. 5 minutes later, propofol 2 mg/kg and atracurium 0.5 mg/kg will be injected. 10 minutes before the surgery, 1.5 ml/kg of normal saline solution will be used intravenously and then 2 mg/kg per hour as an infusion. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of patient information
public Dr. Tohid Karami
Imam Khomeini hospital., Ershad Ave., Modarress Blvd., Urmia., Iran.
Urmia Iran (Islamic Republic of) 57157-89397 +98 44 3345 7286 karami.t@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Tohid Karami
Imam Khomeini hospital., Ershad Ave., Modarress Blvd., Urmia., Iran.
Urmia Iran (Islamic Republic of) 57157-89397 +98 44 3245 7286 karami.t@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Patients undergoing femoral neck fracture surgery Age between 18 to 85 years Patients with physical status one and two according to the criteria of the American Anesthesia Association (ASA I, II) 18 years 85 years Both History of allergy to local anesthetics Use of opioids and analgesics Use of steroids Pregnancy A history of heart failure Having liver and kidney diseases Uncontrolled blood pressure Endocrine diseases Body mass index (BMI) above 40 kg/m2 NC72.2 Fracture of neck of femur Treatment - Drugs N/A Intervention group: First, all patients will receive intravenous midazolam (0.05 mg/kg) and intravenous fentanyl (2 μg/kg) as premedication. 5 minutes later, propofol 2 mg/kg and atracurium 0.5 mg/kg will be injected. 10 minutes before the surgery, in the intervention group; firstly, 1.5 mg/kg intravenously of lidocaine solution 1% will be injected; then the infusion of lidocaine 1% with a dose of 2 mg/kg per hour will be started with a syringe pump infusion device. Control group: First, all patients will receive intravenous midazolam (0.05 mg/kg) and intravenous fentanyl (2 μg/kg) as premedication. 5 minutes later, propofol 2 mg/kg and atracurium 0.5 mg/kg will be injected. 10 minutes before the surgery, 1.5 ml/kg of normal saline solution will be used intravenously and then 2 mg/kg per hour as an infusion. Pain intensity. Timepoint: Recovery, 6, 12 and 24 hours after the intervention. Method of measurement: Visual Analog Scale (VAS ). Administration of fentanyl as analgesic. Timepoint: During 24 hours after the intervention. Method of measurement: no, yes. Systolic blood pressure. Timepoint: Before, recovery, 6, 12 and 24 hours after the intervention. Method of measurement: monotring. Diastolic blood pressure. Timepoint: Before, recovery, 6, 12 and 24 hours after the intervention. Method of measurement: monotring. Oroumia University of Medical Sciences Approved 2022-09-21 Ethics Committee of Urmia University of Medical Sciences Urmia University of Medical Sciences, Resalat street, Jahad Blvd., Urmia, Iran. Urmia West Azarbaijan Iran (Islamic Republic of)