Comparison of epidural injection of different volumes of Bupivacaine 0.5% combined with Methyl prednisolon in the management of low back pain due to disc herniation
Aim is to determine the analgesic effectiveness of 10 and 15 ml of Caudal epidural Bupivacaine 0.5% with Mehtylprednisolone 80 mg injection for discogenic radicular pain control in one level. Method: In a single blinded, single center, randomized control trial with the help of "http://www.randomization.com/" website, seventy patients were included in two equal Intervention 1 and 2 groups at Imam Reza educational Hospital. Inclusion criteria: Patients with disc herniation in one level aged 30-70. Exclusion criteria: history of spinal surgery; canal stenosis; opiate abuse; psychotic disorders; history of allergic reactions to drugs and anatomical disorders in vertebral column. In order to define the effective volume and dose of local anesthetic, Intervention 1 group received 80mg Mehtylprednisolone (Manufactured by Caspian Tamin Darou Iran) in addition to 15ml 0.5%w/v Bupivacaine (75mg) Manufactured by Merck industries in France, from sacral hiatus into Caudal space by 18 Gage Tuohy needle, under fluoroscopy and contrast guidance. Intervention 2 group received 80mg Methylprednisolone in addition to 8ml 0.5%w/v Bupivacaine(40mg) in the same way. After recovery and discharge, Patients' pain score were assessed through the Visual Analogue Scale. Their Range of motion and the need for another block or other modality were recorded. This process would be assessed every month until 6 months and data would be recorded then analyzed and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201607111772N19
Registration date:2016-08-31, 1395/06/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-31, 1395/06/10
Registrant information
Name
Dawood Aghamohammadi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1381 8940
Email address
aghamohammadid@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Faculty of Medicine,Tabriz University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of epidural injection of different volumes of Bupivacaine 0.5% combined with Methyl prednisolon in the management of low back pain due to disc herniation
Public title
Effectiveness of different volume of epidural local anesthetic for low back pain control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with disc herniation in one level; aged 30-70.
Exclusion criteria: canal stenosis; opiate abuse; psychotic disorders history of allergic reactions to drugs; anatomical disorders in vertebral column
Age
From 30 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
By help of randomization site: http://www.randomization.com/
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
unite2, Vice Chancellor for Research, Fuculty of medicine, Tabriz University of Medical Sciences, Daneshghah street, Tabriz
City
Tabriz
Postal code
Approval date
2016-02-04, 1394/11/15
Ethics committee reference number
TBZMED.REC.1394.1010
Health conditions studied
1
Description of health condition studied
Sciatalgia
ICD-10 code
M51.1+
ICD-10 code description
Lumbar and other intervertebral disc disorders with radiculopathy (G55.1*) Sciatica due to intervertebral disc disorder
Primary outcomes
1
Description
Pain
Timepoint
every month until 6th month
Method of measurement
visual analog scale
Secondary outcomes
1
Description
Rang of Motion
Timepoint
every month until 6th month
Method of measurement
leg rise test
Intervention groups
1
Description
Intervention group 1: patients in this group received 80 mg Mehtylprednisolone (Manufactured by Caspian Tamin Darou Iran) plus 15ml 0.5%w/v Bupivacaine (75mg) Manufactured by Merck industries in France from sacral hiatus into Caudal space under fluoroscopy and contrast guidance by 18 Gage Tohy needle.
Category
Treatment - Drugs
2
Description
Intervention group 2: patients in this group received 80mg Methylprednisolone plus 8ml 0.5%w/v Bupivacaine (40mg) from sacral hiatus into Caudal space under fluoroscopy and contrast guidance by 18 Gage Tohy needle.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital/Tabriz
Full name of responsible person
Dawood Aghamohammadi
Street address
Imam Reza Hospital, Tabriz University of Medical Sciences, Daneshghah street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Faculty of Medicine,Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Street address
Vice Chancellor for Research,Tabriz University of Medical Sciencest, Daneshghah Street, Tabriz
City
Tabriz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Faculty of Medicine,Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science
Full name of responsible person
Dawood Aghamohammadi
Position
Associate Professor
Other areas of specialty/work
Street address
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science, Daneshghah street, Tabriz
City
Tabriz
Postal code
Phone
+84 133818940
Fax
Email
aghamohammadid@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science
Full name of responsible person
Dawood Aghamohammadi
Position
Associate Professor
Other areas of specialty/work
Street address
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science, Daneshghah street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3381 8940
Fax
Email
aghamohammadid@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science
Full name of responsible person
Dawood Aghamohammadi
Position
Associate Professor
Other areas of specialty/work
Street address
Anesthesiology Dept, Faculty of Medicine, Tabriz University of Medical Science, Daneshghah street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3381 8940
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)