]>
IRCT20141209020258N181 IRCT 2023-02-25 Arak University of Medical Sciences Comparison of fentanyl and magnesium sulfate intrathecal and intraarticular in pain after knee arthroscopy Comparison of fentanyl and magnesium sulfate intrathecal and intraarticular in pain after knee arthroscopy 2023-03-11 anticipated 140 Complete https://irct.ir/trial/68795 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated into 4 groups using a permuted balanced block randomization method with the size of blocks 4 and 8. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method, Blinding description: In order to make the study double-blind, the data are measured, reviewed and recorded by an intern who is unaware of the groupings, and the preparation of drugs in each group is done by an anesthetist and used during surgery. The patient does not know about the grouping. 2-3 knee arthroscopy. Intervention 1: . Intervention group 1: 100 milligeram magnesium sulfate without preservative (magnesium sulfate used will be 10% and manufactured by Pasteur Institute pharmaceutical company, Tehran-Iran) along with 15 milligeram bupivacaine 0.5% hyperbaric. Intervention 2: Intervention group 2: 8 millileter of 10% magnesium sulfate with 12 millileter of distilled water and a total volume of 20 millileter is administered intra-articularly. Intervention 3: Intervention group 3: 50 micrograms of fentanyl (manufactured by Caspian Tamin Company - Rasht, Iran) along with 15 mg bupivacaine 0.5% hyperbar (heavy) manufactured by Strazenka Company (Cambridge - England) imported by Kobel Daru Company (Tehran - Iran) will be. Intervention 4: Intervention group 4: 50 micrograms of fentanyl (manufactured by Caspian Tamin Company - Rasht, Iran) will be added to 19 ml of 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 There is no more information
public Dr Alireza Sosanabadi
Valiasr Hospital, Valiasr Squre, Shahid Shirodi Street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 sosanabadi@arakmu.ac.ir Arak University of Medical Sciences scientific Dr Hesamedin Modir
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) 18 to 60 years both sexes ASA class 1 and 2 No history of drug use No history of chronic use of painkillers Lack of sensitivity to the drugs used in this study Absence of liver and kidney failure Absence of underlying disease such as high blood pressure, diabetes, history of infection and malignancy, coagulation diseases Candidate patients for knee arthroscopy Absence of body mass index greater than 30 Absence of cardiovascular problems and arrhythmia Lack of psychological problems Absence of peripheral and central neuropathy Absence of local infection in the spinal area 18 years 60 years Both The patient's lack of consent to continue participating in the study The patient's refusal to perform spinal anesthesia Failure to perform spinal anesthesia T84.042D Periprosthetic fracture around internal prosthetic right knee joint, subsequent encounter Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs . Intervention group 1: 100 milligeram magnesium sulfate without preservative (magnesium sulfate used will be 10% and manufactured by Pasteur Institute pharmaceutical company, Tehran-Iran) along with 15 milligeram bupivacaine 0.5% hyperbaric. Intervention group 2: 8 millileter of 10% magnesium sulfate with 12 millileter of distilled water and a total volume of 20 millileter is administered intra-articularly. Intervention group 3: 50 micrograms of fentanyl (manufactured by Caspian Tamin Company - Rasht, Iran) along with 15 mg bupivacaine 0.5% hyperbar (heavy) manufactured by Strazenka Company (Cambridge - England) imported by Kobel Daru Company (Tehran - Iran) will be. Intervention group 4: 50 micrograms of fentanyl (manufactured by Caspian Tamin Company - Rasht, Iran) will be added to 19 ml of normal saline Pain. Timepoint: Recovery and 1, 6, 24 hours after surgery. Method of measurement: Visual Analogue Scale. Average analgesic drug consumption. Timepoint: End of study. Method of measurement: Hospital file. Research Assistant of Arak University of Medical Sciences Approved 2022-12-12 Ethics comittee of Arak University of Medical Sciences Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)