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IRCT20240421061548N1 IRCT 2024-06-18 Ghoum University of Medical Sciences Analgesia of patients undergoing chest intubation Comparative study of Erector Spinae Plane Block in comparison with Intercostal Block in patients in need of chest tube fixation. 2024-07-22 anticipated 60 Complete https://irct.ir/trial/76643 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be assigned to intervention and control groups using block randomized method. The link "https://www.sealedenvelope.com/simple-randomiser/v1/lists" will be used for block randomization. For this purpose, the target number of samples (60 samples), number of groups (two groups A and B) and number of blocks (4) will be entered and the system will provide the researcher with a list of 4 blocks. Based on the output list, it will be determined in which group the patients who enter the study should be placed in order. Items A represent the intervention group and items B represent the control group, Blinding description: Based on the block randomization method, patients will be divided into two control and intervention groups of 30 people. In a group of anesthesiologists who will not know the type of research, they will put the patients under one of the nerve block methods based on the sealed envelope in which the type of block is specified. The principal investigator will not know which patient is receiving which block. The patient and the person filling the questionnaire do not know the type of block. 3 Local anesthesia. Intervention 1: Intervention group: Intervention group (E) under Erector Spinae block: includes 30 patients who, after obtaining consent for nerve block, eligible people, are blocked under aseptic conditions under ultrasound guidance as a random sampling before chest intubation. They receive 15 cc of bupivacaine 0.5% at T5 level. Intervention 2: Control group ; under intercostal block: including 30 patients, after obtaining consent for nerve block, eligible people are randomly sampled before chest intubation, under aseptic conditions under ultrasound guidance. 15 cc of bupivacaine 0.5% is equally divided into three levels: T4, T5-T6. 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 further information.
public Mohamad Hasan Yousefi Najaf Abadi
Beheshti Hospital
Qom Iran (Islamic Republic of) 3719964797 +98 25 3612 2000 Dr.yousefi.ir@gmail.com Ghoum University of Medical Sciences scientific Mohamad Hasan Yousefi Najaf Abadi
Beheshti Hospital
Qom Iran (Islamic Republic of) 3719964797 +98 25 3612 2000 Dr.yousefi.ir@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Age 18-50 years ASA Class I - II 18 years 50 years Both Emergency cases ASA Class III and above History of drug allergy Sensitivity to local anesthetics Psychotic disease Drug addiction Coagulation disorder Local skin infection Chronic use of painkillers and NSAIDs Y48.3 Local anaesthetics Treatment - Drugs Treatment - Drugs Intervention group: Intervention group (E) under Erector Spinae block: includes 30 patients who, after obtaining consent for nerve block, eligible people, are blocked under aseptic conditions under ultrasound guidance as a random sampling before chest intubation. They receive 15 cc of bupivacaine 0.5% at T5 level. Control group ; under intercostal block: including 30 patients, after obtaining consent for nerve block, eligible people are randomly sampled before chest intubation, under aseptic conditions under ultrasound guidance. 15 cc of bupivacaine 0.5% is equally divided into three levels: T4, T5-T6. Pain level. Timepoint: Before, during and after the chest tube insertion. Method of measurement: Patient's pain level based on Visual Analogue Scale. Ghoum University of Medical Sciences Approved 2023-06-26 Research Ethics Committees of Qom University of Medical Sciences No. 83, Shahid Lotfi Niaser Ave, Safashehr Blvd Qom Ghoum Iran (Islamic Republic of)