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IRCT20201003048906N1 IRCT 2021-03-01 Arak University of Medical Sciences effect of dexamethasone and bupivacaine in reduction of pain and disability after discectomy Efficacy of intraoperative epidural dexamethasone and bupivacaine in reduction of pain and disability following lumbar discectomy 2019-11-22 anticipated 42 Complete https://irct.ir/trial/51365 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After selecting the sample, they are randomly divided into two groups of intervention and control. In this study, individuals were assigned to two groups using permutation block method. In this method, a represents the individual receiving the intervention and B represents the individual in the control group. Considering the quadruple block; they were classified into AABB, ABAB, ABBA, BAAB BBAA and BABA permutations and by randomly selection from permutation patients were classified, Blinding description: In double blinding process patients are informated about use of medication which is not harmful .This medication maybe reduces pain after surgery.At the end of surgery the person who was selected previously prepare medication .The medication can be plasebo or combination of dexamethason and bupivacain.Surgeon is not inform about kind of medication.Every patient and medication used for him/her are specified with same number.for example patient: num 8 and medication: num 8. 3 Lumbar disc herniation. Intervention 1: Intervention group: Gelfom is soaked with 2cc dexamethason and 4cc bupivacain (0.5 % solution) aplied on hurted root. Intervention 2: Control group: Gelfom is soaked with 6cc normal salin on hurted root. 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 No more information.
public Aidin Shakeri
Valiasr Square
Arak Iran (Islamic Republic of) 38149557558 +98 86 3222 2004 saebiradreza@gmail.com Arak University of Medical Sciences scientific Aidin Shakeri
Valiasr Square
Arak Iran (Islamic Republic of) 38149557558 0086 86 32222004 saebiradreza@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) patient with unilateral single level disc herniation 17 years 75 years Both Previous same level surgery Multilevel disc herniation Spine instability Qauda equina syndrome Spinal kyphosis and scoliosis Spinal modic change and infection M51.36 Other intervertebral disc degeneration, lumbar region Treatment - Drugs Placebo Intervention group: Gelfom is soaked with 2cc dexamethason and 4cc bupivacain (0.5 % solution) aplied on hurted root Control group: Gelfom is soaked with 6cc normal salin on hurted root Lower limb and back pain. Timepoint: Preoperation and 3,6,12, and 24 hours postoperation. Method of measurement: Visual Analoge Scale. Disability score. Timepoint: befor surgery and 1 and 6 month after surgery. Method of measurement: Oswestry Disability Index. Use of opium dose. Timepoint: 24 hours after surgery. Method of measurement: Base of milligram. Hospitalization period. Timepoint: Period after surgery. Method of measurement: Number of days. Arak University of Medical Sciences Approved 2020-09-06 Ethics committee of Arak University of Medical Science No. 3, Shaghayegh Ave., Jahanpanah Blvd. Arak Markazi Iran (Islamic Republic of)