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IRCT20231223060498N1 IRCT 2024-02-07 Gorgan University of Medical Sciences Investigating the effect of intraspinal narcotic injection on the occurrence of pruritus in patients with opium abuse disorder undergoing orthopedic surgery Evaluation the effect of intrathecal injection on the incidence and severity of pruritus in opium use disorder patients undergoing lower limbs orthopedic surgery 2024-02-20 anticipated 68 Complete https://irct.ir/trial/75050 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The people participating in the study will be assigned to two intervention (FA) and control (MA) groups using the block randomization method. In this way, by using a dice that has 6 faces, the samples are assigned to their groups, a number is written on each face, and each number is assigned to one of the blocks in the table, which has its own state. it shows. Group A (Marcaine) and B (fentanyl and Marcaine). The complete list of randomized blocks will be provided to the principal investigator by the study epidemiology consultant, Blinding description: Blinding in this study is double blinding. So that both the patient does not know which treatment group he is in and the itch evaluator (Investigator) will not be aware of the patient's treatment group type. 3 Condition 1: Patients for elective lower limb fracture surgery(Superficial injury of knee and lower leg). Condition 2: Patients for elective lower limb fracture surgery(Injuries to the ankle and foot). Intervention 1: Intervention group: A group of addicts who will receive intrathecal Marcaine with fentanyl for spinal anesthesia. Intervention 2: Intervention group: A group of addicts who will receive only intrathecal Marcaine for spinal anesthesia. Yes - There is a plan to make this available What will be shared: Information on the main outcome When: 2024 To whom: Researcher working in academic institutions Conditions: Without manipulation, mention the data reference Where to obtain: Mansour.deylami@gmail.com, Gorgan University of Medical Sciences How to obtain: Sending email, mention complete personal and job details with documents Comments:
public Dr. Mansour Deylami
Gorgan - the beginning of Shasat Kala Road - Shadarvan Philosophical Higher Education Complex - Gorgan Medical School
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3115 3311 Mansour.deylami@gmail.com Gorgan University of Medical Sciences scientific Dr. Mansour Deylami
Gorgan - the beginning of Shasat Kala Road - Shadarvan Philosophical Higher Education Complex - Gorgan Medical School
Gorgan Iran (Islamic Republic of) 4913474515 +98 17 3115 3311 Mansour.deylami@gmail.com Gorgan University of Medical Sciences Iran (Islamic Republic of) People addicted to opium, 20-55 years old Anesthesia status in class I and II classification of the American Society of Anesthesiology (ASA) Sign the informed consent form Drug users who are only addicted to opium 20 years 55 years Both Presence of neurological disorders Coagulation problem Presence of local skin infection at the injection site High pressure of cerebrospinal fluid Presence of sensitivity to local anesthetics Cortone use in the last year Taking antihistamine in the last 8 weeks History of food and drug allergy People who use other drugs besides opium S80-S89 S90-S99 Superficial injury of knee and lower leg Injuries to the ankle and foot Treatment - Drugs Treatment - Drugs Intervention group: A group of addicts who will receive intrathecal Marcaine with fentanyl for spinal anesthesia. Intervention group: A group of addicts who will receive only intrathecal Marcaine for spinal anesthesia. Prevalence and intensity itching. Timepoint: prevalence and intensity itching during surgery and recovery. Method of measurement: The severity of itching will be determined based on the extent of the itching area. In this way, itching in one area of the body will be considered mild, itching in two different areas of the body as moderate, and itching in 3 or more separate areas (generalized itching) will consider as severe.​. Gorgan University of Medical Sciences Approved 2023-10-17 Research ethics committee of Golestan University of Medical Sciences Gorgan, 4 km, Sari, Golestan University of Medical Sciences, Gorgan, Iran. Deputy of Research and Technology of Gorgan, Gorgan, Gorgan Gorgan Golestan Iran (Islamic Republic of)