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IRCT20111102007984N28 IRCT 2018-12-17 Iran University of Medical Sciences A comparison of the effects of Triamcinolone and Dexmedetomidine in caudal neuroplasty in chronic low back pain. A comparison of the effects of Triamcinolone and Dexmedetomidine in caudal neuroplasty in chronic low back pain. 2017-09-23 anticipated 50 Complete https://irct.ir/trial/35697 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: En By using the randomized table, they were divided into two equal groups (n=25). The first group (TR) received triamcinolone plus ropivacaine, and the second group (MR) received Dexmedetomidine plus ropivacaine. for caudal neuroplasty, Blinding description: Both drugs are injectable and the injection site of the drug in the patient's body is in same area. Therefore, patients are not aware of the type of drug. Also, the outcome evaluator is unaware of how random allocation. 3 low back pain. Intervention 1: Intervention group: In intervention group 10ml Ropivacaine 0.2%, 50mg Dexmedetomidine (Excir, Iran) and was injected in the caudal epidural space by a catheter under fluoroscopy. Intervention 2: In control group 10ml 0.2% Ropivacaine (Molteni, Italy), 80 mg Triamcinolone (Caspian, IRAN) was injected in the caudal epidural space by a catheter under fluoroscopy. Yes - There is a plan to make this available What will be shared: Part of the clinical information of the patient is shared When: 6 months after the end of the project To whom: Faculty Members of Medical Sciences Universities Conditions: For further studies Where to obtain: Deputy of Research & Technology Pain Research Center Iran University of Medical Sciences How to obtain: First, at the request of the university, she/he will be informed at the request of the university's deputy of the research department, and then she will be referred to the research center during the administrative process and the data will be received by the committee of the research center of the center with a commitment and acceptance. Comments:
public Farnad Imani
Pain Research Center, Department of Anesthesiology and Pain Medicine, Rasool Akram Medical Center, Niayesh St. Sattar Khan St
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6651 5758 farnadimani@yahoo.com Iran University of Medical Sciences scientific Dr. Farnad Imani
Pain Research Center, Department of Anesthesiology and Pain Medicine, Rasool Akram Medical Center, Niayesh St. Sattar Khan St
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6651 5758 farnadimani@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) 1) Chronic low back pain more than six months +/- radiculopathy, 2) Moderate to severe pain score (> 3, based on the Visual Analog Scale),3) Age 40-70 years,4) Inadequate response to conservative and physiotherapy treatments after three months,5) ASA classification I-II,6) Disc protrusion (at MRI) 40 years 70 years Both 1) Severe canal stenosis (more than two thirds in axial MRI view), 2) Sequestrated disc (fragmented),3) Decreased disc height more than 60%,4) Sever spinal deformity,5) Spinal tumors,6) Vertebral fracture,7) Spondylolisthesis > Grade II, 8) Local or systemic infection, 9) Taking anticoagulants,10) Drug abuse,11) History of drug reaction,12) Sever psychological disorders,13) Pregnancy and lactation,14) Severe or sudden neurological deficit such as urinary or fecal incontinence,15) Body Mass Index (BMI) > 35,16) Patient's refusal,17) Diabetes mellitus, 18) MRI contraindications (cardiac pacemaker, defibrillator, aortic aneurysm clips),19)Impossible prone positioning M54.5 Low back pain Treatment - Drugs Treatment - Drugs Intervention group: In intervention group 10ml Ropivacaine 0.2%, 50mg Dexmedetomidine (Excir, Iran) and was injected in the caudal epidural space by a catheter under fluoroscopy. In control group 10ml 0.2% Ropivacaine (Molteni, Italy), 80 mg Triamcinolone (Caspian, IRAN) was injected in the caudal epidural space by a catheter under fluoroscopy Low back pain. Timepoint: Before injection,two weeks,1,3 and 6 month after intervention. Method of measurement: pain score measured with visual analogue scale in Questionnaire. Oswestry Disability Index questionnaire (ODI) and straight leg raising test (SLR), Reverse straight leg raising test (RSLR),Bonnet,FABER,Gaenslen,Tiptoe and Heel walking,analgesic consumption,blood sugar,HbA1C,MRI. Timepoint: Before injection, two weeks, 1,3 and 6 moth after intervention. Blood sugar ,before injection,2 th day and 2th week after injectionHbA1C, before injection,3 and 6 month after injection MRI, before injection and 6 month after injection. Method of measurement: Questionnaire. Iran University of Medical Sciences Approved 2018-07-25 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Expressway corner Tehran Tehran Iran (Islamic Republic of)