The comparison of targeted spinal nerve root blockade with caudal vs transforaminal approach in lumbar radiculopathy

The comparison of targeted spinal nerve root blockade with caudal vs tansforaminal approach in lumbar radiculopathy

This randomized, double blinded, clinical trial at phase 2 is done on 50 patients. The sample size based on the formula n = (2 (z1-α / 2 + z1-b) ²δ² / d² ، is 50 patients which randomly divided into two equal groups.

This study is done in patients in operation room, under aseptic condition, local anesthesia, monitoring, on prone position, by fluoroscopic guidance. Patients is divided into Transforaminal (T), and Caudal (C) groups. In T 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, injectate for each level (Triamcinolone 20mg, and Ropivacaine %0.1, 5ml) is injected. In C group, Caudal Racz needle G17 is introduced, and Racz catheter is conducted up to involved levels, and injectate for each level (as same as T group) is injected. After procedure, patients are transferred to recovery and is discharged in case of hemodynamic stability.

Inclusion criteria: Radicular moderate to sever low back pain, Lack of response to conservative therapy. Exclusion criteria: severe spinal deformity, infection, 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, history of lumbar spine surgery, peripheral neuropathy

Transforaminal (T), and Caudal (C) groups

Visual Analogue Scale , Oswestry Disability Index , analgesia consumption

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

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.

Some part of the clinical information of the patients will be shared

One year after the end of the project

Faculty Members of Medical Sciences Universities

For further studies

Deputy of Research & Technology, and Pain Research Center, Iran University of Medical Sciences

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.