comparison of pain score following caudal block with ropivacaine and triamcinolone and magnesium sulfate as adjuvant in patients with low back pain.
Design
Randomized double blind clinical trial with control group, phase 3 on 40 patients. Rand function of Excel was used for randomization.
Settings and conduct
patients with low back pain who refer to pain clinic of Imam Hussain Hospital will be divided in two groups recruiting software blocked randomization. Detection of caudal canal will be confirmed using injection of 2 ml of radio opaque contrast solution. Following negative aspiration of CSF or blood, 10 ml of ropivacaine 0.1% in conjunction with 40 triamcinolone or 200 milligram magnesium sulfate will be injected. The patient will be monitored 30 minutes postoperatively for hemodynamic stability and presence of adverse effects. Demographic data and MRI findings will be recorded.Pain scores based on numeric rating scale and Modified Oswestry Disability Questionnaire preoperatively and 1 and 3 month postoperatively will be recorded.
Participants/Inclusion and exclusion criteria
Inclusion:
Patients with low back pain at least 3 month before, no response to physiotherapy least 6 month and NRS>=4 and age between 30-60 yrs/o
Exclusion:
epidural steroid injection during last 3 month, coagulopathy, pregnancy, breast feeding, sensitivity to contrast medium, psychiatric disease, hemodynamic and respiratory unstability, previous back surgery, local anesthetic sensitivity, local infection, patient's refusal.
Intervention groups
Patients with low back pain
Main outcome variables
comparison of triamcinolone and magnesium sulfate as adjuvant with ropivacaine 0.1% for caudal block on pain score in patients with low back pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230502058054N1
Registration date:2023-07-18, 1402/04/27
Registration timing:prospective
Last update:2023-07-18, 1402/04/27
Update count:0
Registration date
2023-07-18, 1402/04/27
Registrant information
Name
Payman ِDadkhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7758 3043
Email address
pdadkhah@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the of effects Magnesium Sulfate and triamcinolone as Adjuvants with Ropivacaine for caudal block in Low Back Pain
Public title
Comparison the of effects Magnesium Sulfate and triamcinolone as Adjuvants with Ropivacaine for caudal block in Low Back Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with low back pain who have had canal stenosis, multiple disc herniation or multiple degenerative joint disease(based on MRI report), with at least 3 months pain and non responsive to conservative treatments such as physiotherapy with pain score of at least 4 between 30-60 years old.
Exclusion criteria:
Patients with :1-epidural steroid injection during last 3 months, without previous MRI report.2- coagulation disorders 3- pregnant 4- women with milk feeding 5- sensitivity to radiology contrast medications 5- patients with psychological disease 6- unstable hydrodynamic status. 7- previous back surgery 8- contraindication for local anesthetic drugs.9- infection 10- Allergy to medications( local anesthetic, steroid or magnesium) 11- unwillingness of patients to study 12- patients who do not sign inform consent.
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Web based randomization: This service permits patient randomization into one of two or more treatment arms at any time without incurring the need for personnel continuously present at the central site at all times. The only prerequisite is the availability of a computer workstation equipped with an internet link and a standard browser for the world wide web.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study participants, care provider, investigator, outcome assessor and data analyst are all blinded to patients groups.
Placebo
Not 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
Tehran- Velenjac-Shahid Shahriari square-Shahid Arabi St-Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-05-03, 1402/02/13
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.070
Health conditions studied
1
Description of health condition studied
Patients with low back pain who have spinal canal stenosis or several disc bulging or protrusion or degeneration changes in MRI
ICD-10 code
M54.4
ICD-10 code description
low back with sciatica
Primary outcomes
1
Description
Comparison of magnesium sulfate and triamcinolone as adjuvant with ropivacaine for caudal block on pain score in patients with low back pain
Timepoint
Preblock and 1 and 3 month after block
Method of measurement
numeric rating scale
Secondary outcomes
1
Description
modified Oswestry disability questionnaire score
Timepoint
Preblock and 1 and 3 month after block
Method of measurement
Questionnaire score
Intervention groups
1
Description
Intervention group: Magnesium Sulfate
Category
Treatment - Drugs
2
Description
Intervention group: Triamcinolone
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein pain clinic
Full name of responsible person
Alireza Jaffari
Street address
Imam Hussein Square, Shahid Madani st
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
alirezajaffari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Afshin Zarghi
Street address
Velenjac, Shahid Shahriari square, Shahid Araabi st, Shahid Behehshti University of Medical Sciences, 5th Floor
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?