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IRCT20111102007984N32 IRCT 2022-09-02 Iran University of Medical Sciences A comparison of the effects of Triamcinolone and Dexmedetomidine and Magnesium sulfate in caudal neuroplasty in chronic low back pain A comparison of the effects of Triamcinolone and Dexmedetomidine and Magnesium sulfate in caudal neuroplasty in chronic low back pain 2020-03-03 anticipated 60 Complete https://irct.ir/trial/49010 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the Restricted randomization method (block randomization) will be used. Blocking is usually used to balance the number of samples assigned to each of the study groups. All blocks are equal and we will have 8 blocks (including 2 participants in each group) in this experiment, Blinding description: The senior resident who performs all assessments, data collection, and follow-up of the patient will be unaware of how randomly grouped patients are. The pain specialist who performs the intervention will be blind to the grouping or materials used. The patient will also be unaware of the intervention she/he is receiving. 1-2 Low Back Pain. Intervention 1: Control group: which undergoes epidural epidural injection using 2-3 ml of Xylocaine (without preservative and without epinephrine) by a 17-gauge spinal injection needle. Intervention 2: First Intervention group: Intervention group: In addition to epidural injection of caudal (as in the control group), the injection solution containing 10 ml of rupivacaine 0.2%, 10 ml of hypertonic sodium 5% and 1500 units of hyalase with 80 mg of triamcinolone is injected via epidural caudal injection. Intervention 3: Second intervention group: In addition to epidural injection of caudal (as in the control group) received an injection solution similar to the first intervention group, with the difference that instead of triamcinolone, dexmedetomidine is added 0.5 micrograms per kilogram. Intervention 4: Third intervention group: In addition to epidural injection of caudal (like the control group) received an injection solution similar to the first intervention group, with the difference that instead of triamcinolone, magnesium sulfate 50 mg is added. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Farnad Imani
Hazrate Rasoole Akram Hospital,Niayesh St,Satarkhan Av,Tehran, Iran.
Tehran Iran (Islamic Republic of) ۱۴۴۵۶۱۳۱۳۱ +98 21 6651 5758 Farnadimani@yahoo.com Iran University of Medical Sciences scientific Farnad Imani
Hazrate Rasoole Akram Hospital,Niayesh St,Satarkhan Av, Tehran, Iran.
Tehran Iran (Islamic Republic of) ۱۴۴۵۶۱۳۱۳۱ +98 21 6651 5758 Farnadimani@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Chronic low back pain more than six months +/- radiculopathyModerate to severe pain score (> 3, based on the Visual Analog Scale)Being at the age of 40-70 years Inadequate response to conservative and physiotherapy treatments after three monthsAmerican Anesthesiologists Classification (ASA) I-IIDisc protrusion in MRI 40 years 70 years Both Severe canal stenosis (more than two thirds in axial MRI view) Sequestrated disc (fragmented) Decreased disc height more than 60% Sever spinal deformity Spinal tumors Vertebral fracture Spondylolisthesis Grade>2 Local or systemic infection Taking anticoagulants Drug abuse History of drug reaction Sever psychological disorders Pregnancy and lactation Severe or sudden neurological deficit such as urinary or fecal incontinence Body Mass Index (BMI) > 35 Patient's refusal Diabetes mellitus MRI contraindications (cardiac pacemaker, defibrillator, aortic aneurysm clips) Impossible prone positioning M54.5 Low back pain Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: which undergoes epidural epidural injection using 2-3 ml of Xylocaine (without preservative and without epinephrine) by a 17-gauge spinal injection needle. First Intervention group: Intervention group: In addition to epidural injection of caudal (as in the control group), the injection solution containing 10 ml of rupivacaine 0.2%, 10 ml of hypertonic sodium 5% and 1500 units of hyalase with 80 mg of triamcinolone is injected via epidural caudal injection. Second intervention group: In addition to epidural injection of caudal (as in the control group) received an injection solution similar to the first intervention group, with the difference that instead of triamcinolone, dexmedetomidine is added 0.5 micrograms per kilogram. Third intervention group: In addition to epidural injection of caudal (like the control group) received an injection solution similar to the first intervention group, with the difference that instead of triamcinolone, magnesium sulfate 50 mg is added. Visual analog scale. Timepoint: At the beginning of the study (before the intervention) and 14, 30, 90 and 180 days after the intervention. Method of measurement: Visual Analogue Scale. Oswestry Disability Index. Timepoint: At the beginning of the study (before the intervention) and 14, 30, 90 and 180 days after the intervention. Method of measurement: Oswestry Low Back Pain Disability Questionnaire. The amount of painkiller used. Timepoint: At the beginning of the study (before the intervention) and 14, 30, 90 and 180 days after the intervention. Method of measurement: Preset form for recording the amount of painkiller used. Iran University of Medical Sciences Approved 2020-01-08 Ethics committee of Iran University of Medical Sciences Rasoul Akram Hospital, Maziar Mansouri St, Sattar Khan St. Tehran Tehran Iran (Islamic Republic of)