Aim was evaluation efficacy of intraoperative epidural dexamethasone and bupivacaine in reduction of pain and disability following lumbar discectomy.
Design
Randomized clinical trial with intervention and control groups; Double blind; Simple blocked randomized; 42 patients.
Settings and conduct
The patients are visited in valiasr hospital of arak .Patient with diagnose of unilateral single level lumbar disc herniation will condidate for surgery.42 patients in two groups are studied. for control group are used plasebo and for intervention group are used combination of dexamethason and bupivacain
Participants/Inclusion and exclusion criteria
Unilateral single level lumbar disc herniation
Intervention groups
The patients are studied in two groups.in intervention group combination of dexamethasone and bupivacain are used and for control group plasebo are used.
Main outcome variables
Low back pain, lower extremities and severe disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201003048906N1
Registration date:2021-03-01, 1399/12/11
Registration timing:retrospective
Last update:2021-03-01, 1399/12/11
Update count:0
Registration date
2021-03-01, 1399/12/11
Registrant information
Name
Reza Saebirad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4465 6335
Email address
saebiradreza@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of intraoperative epidural dexamethasone and bupivacaine in reduction of pain and disability following lumbar discectomy
Public title
effect of dexamethasone and bupivacaine in reduction of pain and disability after discectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient with unilateral single level disc herniation
Exclusion criteria:
Previous same level surgery
Multilevel disc herniation
Spine instability
Qauda equina syndrome
Spinal kyphosis and scoliosis
Spinal modic change and infection
Age
From 17 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the sample, they are randomly divided into two groups of intervention and control. In this study, individuals were assigned to two groups using permutation block method. In this method, a represents the individual receiving the intervention and B represents the individual in the control group. Considering the quadruple block; they were classified into AABB, ABAB, ABBA, BAAB BBAA and BABA permutations and by randomly selection from permutation patients were classified.
Blinding (investigator's opinion)
Double blinded
Blinding description
In double blinding process patients are informated about use of medication which is not harmful .This medication maybe reduces pain after surgery.At the end of surgery the person who was selected previously prepare medication .The medication can be plasebo or combination of dexamethason and bupivacain.Surgeon is not inform about kind of medication.Every patient and medication used for him/her are specified with same number.for example patient: num 8 and medication: num 8
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Science
Street address
No. 3, Shaghayegh Ave., Jahanpanah Blvd.
City
Arak
Province
Markazi
Postal code
38149-5-7558
Approval date
2020-09-06, 1399/06/16
Ethics committee reference number
IR.ARAKMU.REC.1399.185
Health conditions studied
1
Description of health condition studied
Lumbar disc herniation
ICD-10 code
M51.36
ICD-10 code description
Other intervertebral disc degeneration, lumbar region
Primary outcomes
1
Description
Lower limb and back pain
Timepoint
Preoperation and 3,6,12, and 24 hours postoperation
Method of measurement
Visual Analoge Scale
2
Description
Disability score
Timepoint
befor surgery and 1 and 6 month after surgery
Method of measurement
Oswestry Disability Index
Secondary outcomes
1
Description
Use of opium dose
Timepoint
24 hours after surgery
Method of measurement
Base of milligram
2
Description
Hospitalization period
Timepoint
Period after surgery
Method of measurement
Number of days
Intervention groups
1
Description
Intervention group: Gelfom is soaked with 2cc dexamethason and 4cc bupivacain (0.5 % solution) aplied on hurted root
Category
Treatment - Drugs
2
Description
Control group: Gelfom is soaked with 6cc normal salin on hurted root
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Aidin Shakeri
Street address
Valiasr Square
City
Arak
Province
Markazi
Postal code
38149557558
Phone
+98 86 3222 2004
Fax
Email
valiasrhospital@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Arsh Anoshirvani
Street address
3819693345, Vice Chancellor for Research, Arak University of Medical Sciences, Sardasht, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3222 2004
Email
valiasrhospital@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Aidin Shakeri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Valiasr Square
City
Arak
Province
Markazi
Postal code
38149557558
Phone
+98 86 3222 2004
Email
saebiradreza@gmail.com
Web page address
https://www.arakmu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Aidin Shakeri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Valiasr Square
City
Arak
Province
Markazi
Postal code
38149557558
Phone
0086 86 32222004
Email
saebiradreza@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Reza Saebirad
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Valiasr Square
City
Arak
Province
Markazi
Postal code
38149-55-7558
Phone
+98 86 3222 2004
Email
saebiradreza@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available