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IRCT20111102007984N31 IRCT 2022-01-14 Iran University of Medical Sciences Comparison of the effect of lumbar spinal nerve root block by transforminal and codal method on nerve involved in low back pain The comparison of targeted spinal nerve root blockade with caudal vs transforaminal approach in lumbar radiculopathy 2022-02-20 anticipated 50 Complete https://irct.ir/trial/53618 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we use the block randomization method so that after selecting patients according to the inclusion and exclusion criteria by selecting numbers from the table of random numbers and adapting to the blocks, patients are divided into study groups. To randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks. For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit. Here, based on the block, we divide 4 people into groups. 1. TTCC 2. TCTC 3. TCCT 4. CCTT 5. CTCT 6. CTTC, Blinding description: In this study, people who are responsible for patient care and analysis of statistical data do not know about the treatment process and study groups, and information is provided to them in groups A and B. 2-3 Lumbar spinal nerve root block, Transforminal, Kudal, Lumbar radiculopathy. Intervention 1: Intervention group: Intervention group: In Transforaminal group, blunt curved tip Racz needle G21 is introduced for each involved levels, under transverse process and pedicle conjunction by tunnel view, and after confirmation of correct position of the tip of needle transuraminal block injection solution is administered slowly. The solution for injection in the triamcinolone group (T) contains 20 mg of triamcinolone (triamcinolone acetonide, elixir, Iran) and 0.2% rupivacaine 5 ml (rupivacaine multeni, Italy). In case of involvement of more than one spinal nerve root, the same amount is prescribed for the next levels (up to two levels, one or two sides). In the caudal group (C), the injection is the same as for the transformaminal group for each level. Intervention 2: Control group: In the caudal group, the Racz epidural needle No. 17G enters the caudal space, and the Racz catheter enters the caudal space, and is guided to each level involved, and the drug is injected into the affected surface.Injected drugs include 20 mg of triamcinolone (triamcinolone acetonide, elixir, Iran) and 5 ml of 0.5% ropivacaine (rupivacaine multeni, Italy). Yes - There is a plan to make this available What will be shared: Some part of the clinical information of the patients will be shared When: One year 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, and 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/he will be referred to the pain research center during the administrative process and the data will be received by the committee of the pain research center of the center with a commitment and acceptance. Comments:
public Farnad Imani
Pain Research Center, Rasool Akram Hospital, Niayesh St. Sattarkhan St.
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 6651 5758 farnadimani@yahoo.com Iran University of Medical Sciences scientific Farnad Imani
Hazrate Rasoole Akram Hospital,Niayesh St,Satarkhan Av, Tehran, 1449614535, IRAN
Tehran Iran (Islamic Republic of) ۱۴۴۵۶۱۳۱۳۱ +98 21 6651 5758 farnadimani@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Radicular unilateral or bilateral low back pain more than six months Maximum two levels involved Age 40 to 70 years Lack of response to conservative therapy after three months ASA I-II Moderate to sever pain (VAS > 3) 40 years 70 years Both Severe spinal deformity Spinal tumors Spine fracture Vertebral listاsis more than G II Local or systemic infection Taking anticoagulants Drug abuse History of allergic reaction to the studied drugs History of severe psychological disorders Pregnancy and lactation Severe or sudden onset of neurological complications such as urinary or fecal incontinence BMI>35 Patient refusal MRI contraindication such as pacemakers, defibrillators, aortic aneurysm clips Respiratory incompetence cause prone position intolerance Smoking or alcohol consumption History of lumbar spine surgery Peripheral neuropathy such as diabetes M54.5 Low back pain Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: In Transforaminal group, blunt curved tip Racz needle G21 is introduced for each involved levels, under transverse process and pedicle conjunction by tunnel view, and after confirmation of correct position of the tip of needle transuraminal block injection solution is administered slowly. The solution for injection in the triamcinolone group (T) contains 20 mg of triamcinolone (triamcinolone acetonide, elixir, Iran) and 0.2% rupivacaine 5 ml (rupivacaine multeni, Italy). In case of involvement of more than one spinal nerve root, the same amount is prescribed for the next levels (up to two levels, one or two sides). In the caudal group (C), the injection is the same as for the transformaminal group for each level. Control group: In the caudal group, the Racz epidural needle No. 17G enters the caudal space, and the Racz catheter enters the caudal space, and is guided to each level involved, and the drug is injected into the affected surface.Injected drugs include 20 mg of triamcinolone (triamcinolone acetonide, elixir, Iran) and 5 ml of 0.5% ropivacaine (rupivacaine multeni, Italy). Visual Analogue Scale. Timepoint: Before, two weeks and one month, and three months after the procedure. Method of measurement: based on questionnaire. Oswestry Disability Index. Timepoint: One, and three months after the procedure. Method of measurement: Based on the questionnaire. The amount of analgesia consumption. Timepoint: One, and three months after the procedure. Method of measurement: Record and take notes. Iran University of Medical Sciences Approved 2021-01-11 Iran University of Medical Sciences, Tehran, Iran Rasool Akram Hospital, Niayesh St, Satarkhan Av. Tehran Tehran Iran (Islamic Republic of)