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IRCT20190325043107N31 IRCT 2023-03-17 Shahid Beheshti University of Medical Sciences Comparison of caudal epidural method with S1 transforaminal block in patients undergoing lumbar discectomy Comparison of caudal epidural method with S1 transforaminal block in patients undergoing lumbar discectomy with symptoms of post-surgery failure syndrome. 2023-04-03 anticipated 52 Complete https://irct.ir/trial/69177 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the block random division method (blocks of 4) is used. One of the colleagues of the study, who was not blinded, names the caudal block method with the letter A and the transforaminal block method with the letter B. Then, the researcher distributes packages A and B among the referring patients in order to participate in the study using a block random division method (of 4). Then, among the created blocks, so many blocks are randomly selected to reach the required sample size. To make a random sequence, we give numbers from 1 to 13 to the possible blocks (13 blocks). According to the sample size, any number of 4 blocks will be used. Block numbers will be selected from the table of random numbers and the sequence of blocks in each group will be determined based on these numbers. Finally, with the help of 13 blocks of four, random allocation will be done, Blinding description: The first researcher will divide the patients into study groups using blocks of four and complete the relevant checklists and hand them over to the statistical consultant. The statistical consultant will be blinded to which groups the patients fall into. Also, patients will be unaware of the type of drug injected; Therefore, the patients will also be blind during the study; Therefore, this study will be conducted in a double-blind manner. 2-3 Pain. Intervention 1: Intervention group1: The patient is placed in the prone position and a pillow is placed under the abdomen to increase access to the lumbar position. After prep and drape, the target sacral surface for the block is identified under ultrasound guidance after hitting the trajectory. The surgeon enters the area with a #22 spinal needle and one cc of lidocaine will be injected. After reaching the inferomedial pedicle, four cc of triamcinolone drug and 4 cc of normal saline will be injected. Pain intensity will be measured before the intervention and one month and three months after the intervention using the VAS tool. Intervention 2: Intervention group2: The patient is placed in the prone position and a pillow is placed under the abdomen to increase access to the lumbar position. After prep and drape, the target sacral surface for the block is identified under ultrasound guidance after hitting the trajectory. The surgeon enters the area with a #22 spinal needle and one cc of lidocaine will be injected. After reaching the inferomedial pedicle, four cc of triamcinolone drug, 2 cc of ropivacaine drug and 2 cc of normal serum will be injected. Pain intensity will be measured before the intervention and one month and three months after the intervention using the VAS tool. 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 Mehdi Khanbabayi Gol
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences scientific Mehdi Khanbabayi Gol
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients who underwent lumbar discectomy and have lower radicular pain symptoms. Consent to participate in the research project 18 years 65 years Both Taking anticoagulant drugs Systemic infection History of severe heart disease Lumbar infection G89.29 Other chronic pain Treatment - Drugs Treatment - Drugs Intervention group1: The patient is placed in the prone position and a pillow is placed under the abdomen to increase access to the lumbar position. After prep and drape, the target sacral surface for the block is identified under ultrasound guidance after hitting the trajectory. The surgeon enters the area with a #22 spinal needle and one cc of lidocaine will be injected. After reaching the inferomedial pedicle, four cc of triamcinolone drug and 4 cc of normal saline will be injected. Pain intensity will be measured before the intervention and one month and three months after the intervention using the VAS tool. Intervention group2: The patient is placed in the prone position and a pillow is placed under the abdomen to increase access to the lumbar position. After prep and drape, the target sacral surface for the block is identified under ultrasound guidance after hitting the trajectory. The surgeon enters the area with a #22 spinal needle and one cc of lidocaine will be injected. After reaching the inferomedial pedicle, four cc of triamcinolone drug, 2 cc of ropivacaine drug and 2 cc of normal serum will be injected. Pain intensity will be measured before the intervention and one month and three months after the intervention using the VAS tool. Pain. Timepoint: Before the intervention, one month and three months after the intervention. Method of measurement: Visual Analog Scale (VAS). Shahid Beheshti University of Medical Sciences Approved 2023-03-04 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences Tehran East Azarbaijan Iran (Islamic Republic of)