Comparison of caudal epidural method with S1 transforaminal block in patients undergoing lumbar discectomy with symptoms of post-surgery failure syndrome.
Comparison of caudal epidural method with S1 transforaminal block in patients undergoing lumbar discectomy with symptoms of post-surgery failure syndrome.
Design
This study will be conducted as a randomized clinical trial (blocks of four), double-blind (statistical consultant and patient), without control group, with parallel groups and with 2-3 phase with the participation of 52 patients after discectomy.
Settings and conduct
This randomized clinical trial study will be conducted with the participation of 52 patients referred to Imam Hossein Hospital (Shahid Beheshti University of Medical Sciences) with lower limb radicular symptoms after discectomy surgery. Patients will be randomly divided into two groups, caudal block and transforaminal block, and the pain intensity after the intervention will be compared between the two groups. The patients and the statistical consultant will be blinded during the study and the study will be conducted in a double-blind manner.
Participants/Inclusion and exclusion criteria
The criteria for entering the study are patients who underwent lumbar discectomy and have lower radicular pain symptoms and consent to participate in the research plan, and the exclusion criteria also include: use of anticoagulant drugs, systemic infection, history of severe heart diseases and lumbar infection .
Intervention groups
This study is a randomized clinical trial without a control group, which will be conducted with the participation of 52 patients after lumbar discectomy surgery. Patients will be divided into two treatment methods, caudal block and transforaminal block, and the intensity of pain will be compared in them after the intervention.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N31
Registration date:2023-03-17, 1401/12/26
Registration timing:prospective
Last update:2023-03-17, 1401/12/26
Update count:0
Registration date
2023-03-17, 1401/12/26
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-03, 1402/01/14
Expected recruitment end date
2023-08-05, 1402/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of caudal epidural method with S1 transforaminal block in patients undergoing lumbar discectomy with symptoms of post-surgery failure syndrome.
Public title
Comparison of caudal epidural method with S1 transforaminal block in patients undergoing lumbar discectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who underwent lumbar discectomy and have lower radicular pain symptoms.
Consent to participate in the research project
Exclusion criteria:
Taking anticoagulant drugs
Systemic infection
History of severe heart disease
Lumbar infection
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block random division method (blocks of 4) is used. One of the colleagues of the study, who was not blinded, names the caudal block method with the letter A and the transforaminal block method with the letter B. Then, the researcher distributes packages A and B among the referring patients in order to participate in the study using a block random division method (of 4). Then, among the created blocks, so many blocks are randomly selected to reach the required sample size. To make a random sequence, we give numbers from 1 to 13 to the possible blocks (13 blocks). According to the sample size, any number of 4 blocks will be used. Block numbers will be selected from the table of random numbers and the sequence of blocks in each group will be determined based on these numbers. Finally, with the help of 13 blocks of four, random allocation will be done.
Blinding (investigator's opinion)
Double blinded
Blinding description
The first researcher will divide the patients into study groups using blocks of four and complete the relevant checklists and hand them over to the statistical consultant. The statistical consultant will be blinded to which groups the patients fall into. Also, patients will be unaware of the type of drug injected; Therefore, the patients will also be blind during the study; Therefore, this study will be conducted in a double-blind manner.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences
City
Tehran
Province
East Azarbaijan
Postal code
5165665631
Approval date
2023-03-04, 1401/12/13
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.875
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89.29
ICD-10 code description
Other chronic pain
Primary outcomes
1
Description
Pain
Timepoint
Before the intervention, one month and three months after the intervention
Method of measurement
Visual Analog Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: The patient is placed in the prone position and a pillow is placed under the abdomen to increase access to the lumbar position. After prep and drape, the target sacral surface for the block is identified under ultrasound guidance after hitting the trajectory. The surgeon enters the area with a #22 spinal needle and one cc of lidocaine will be injected. After reaching the inferomedial pedicle, four cc of triamcinolone drug and 4 cc of normal saline will be injected. Pain intensity will be measured before the intervention and one month and three months after the intervention using the VAS tool.
Category
Treatment - Drugs
2
Description
Intervention group2: The patient is placed in the prone position and a pillow is placed under the abdomen to increase access to the lumbar position. After prep and drape, the target sacral surface for the block is identified under ultrasound guidance after hitting the trajectory. The surgeon enters the area with a #22 spinal needle and one cc of lidocaine will be injected. After reaching the inferomedial pedicle, four cc of triamcinolone drug, 2 cc of ropivacaine drug and 2 cc of normal serum will be injected. Pain intensity will be measured before the intervention and one month and three months after the intervention using the VAS tool.