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IRCT20220904055873N1 IRCT 2022-10-10 Iran University of Medical Sciences Comparison between ultrasound guided periarterial femor block and femoral nerve block effects in anterior cruciate ligament surgery under general anesthesia Comparison between ultrasound guided periarterial femor block and femoral nerve block on intraoperative hypertensionduring tourniquet closure in anterior cruciate ligament surgery under general anesthesia: a double-blind randomized clinical trial 2022-11-06 anticipated 50 Complete https://irct.ir/trial/65981 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization we use block randomization method.we put patients in two groups and use www.sealedenvelope.com website for making sequence.In each block we have 5 cases. We use A for group who are having periarterial femoral block and use B for the second group (classic femoral block). Then we have A and B sequences in 10 blocks for 50 cases which will be divided into two groups containing 25 cases.At last we put cards with the blocks written on them in envelopes. by this method allocation concealment is done, Blinding description: The observer and patient dosen't know type of the block.The procedure is done when the patient put under general anesthesia. The patient and the person who observe the patient are unaware of block type. N/A Condition 1: Knee surgery. Condition 2: ACL surgery. Condition 3: Femoral block. Intervention 1: Intervention group: Periarterial femoral block for patients between 18 to 75 years who are having ACL surgery under general anesthesia. Patients in each group are routinely anesthetized(with Propofol,Fentanyl , Midazoalm and Cisatracrium according to patient weight) . First group are having Periarterial femoral block under ultrasound guidance with 15cc rupivacaine 0.5% then needed data is observed during and after general anesthesia. Intervention 2: Intervention group: femoral block for patients between 18 to 75 years who are having ACL surgery under general anesthesia.Patients in each group are routinely anesthetized(with Propofol,Fentanyl , Midazoalm and Cisatracrium according to patient weight) . First group are having calssic femoral nerve block under ultrasound guidance with 15cc rupivacaine 0.5% then needed data is observed during and after general anesthesia. No - There is not a plan to make this available Justification or reason for not sharing IPD is no more information
public Arezoo Hossienkhani
No.12, Minoo street, Sadeghie Gomi street, Nivaran street.
Tehran Iran (Islamic Republic of) 1976845676 +98 21 2273 6391 Parham_c11@yahoo.com Iran University of Medical Sciences scientific Arezoo Hossienkhani
No.12, Minoo street, Sadeghie Gomi street, Nivaran street.
Tehran Iran (Islamic Republic of) 1976845676 +98 21 2273 6391 Parham_c11@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) oral and written consent Being at the age of 18-75 years old ACL surgery Weight more than 50kg 18 years 75 years Both Patient diagnosed with chronic pain Opium addiction or other drugs pregnancy local infection Allergy to local anesthetic weight less than 50 or BMI more than 30 Coagulopathy Patient unable to evaluate pain score Chronic uncontrolled disease Blood loss more than 500 cc during surgery Surgery duration longer than 3 hours Treatment - Drugs Treatment - Drugs Intervention group: Periarterial femoral block for patients between 18 to 75 years who are having ACL surgery under general anesthesia. Patients in each group are routinely anesthetized(with Propofol,Fentanyl , Midazoalm and Cisatracrium according to patient weight) . First group are having Periarterial femoral block under ultrasound guidance with 15cc rupivacaine 0.5% then needed data is observed during and after general anesthesia. Intervention group: femoral block for patients between 18 to 75 years who are having ACL surgery under general anesthesia.Patients in each group are routinely anesthetized(with Propofol,Fentanyl , Midazoalm and Cisatracrium according to patient weight) . First group are having calssic femoral nerve block under ultrasound guidance with 15cc rupivacaine 0.5% then needed data is observed during and after general anesthesia. Pain during surgery. Timepoint: During surgery. Method of measurement: ANI (anlgesia nociception index). Post operation pain. Timepoint: after surgery. Method of measurement: Visual Analogue Scale (VAS). Mean arterial blood pressure before inflating tourniquet and after deflating. Timepoint: 10 minutes interval 3 times. Method of measurement: arterial line. Mean arterial blood pressure after inflating of tourniquet. Timepoint: Every 15 minutes till the end of surgery. Method of measurement: Arterial line. Anesthesia depth. Timepoint: Every 30 minutes till the end of general surgery. Method of measurement: Bispectral index(BIS). Iran University of Medical Sciences Approved 2022-04-23 Ethics committee of Iran University of Medical Sciences ran University of Medical Sciences; Hemmat highway Tehran Tehran Iran (Islamic Republic of)