This study which was performed as a triple blind clinical trial, aimed to evaluate the effect of Methylene blue on the improvement of postoperative pain and quality of life (QOL)after lumbar laminectomy and discectomy. A total of 115 patients who should be operated for lumbar spinal canal stenosis or the herniation of degenerative disc in one level or multiple levels were selected, alternatively. Methylene blue 0.5% with a dose of 1cc was injected to 56 patients (study group) and 59 other patients received normal saline for covering dura hemostasis (control group). The patients with a history of laminectomy or discectomy surgical operation who are now under a repeated surgery and also those with infection were excluded. In both groups, pain and functional QOL were evaluated before and 3 months after the surgical operation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138807142193N4
Registration date:2011-06-24, 1390/04/03
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-06-24, 1390/04/03
Registrant information
Name
Majid Reza Farrokhi
Name of organization / entity
Shiraz Neurosciences Research Center, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1623 4508
Email address
neuroscien@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research affairs of Shiraz University of Medical Sciences and Health Services-Shiraz University of Medical Sciences
Expected recruitment start date
2011-07-23, 1390/05/01
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of methylene blue on postoperative pain and quality of life after lumbar laminectomy and discectomy
Public title
Determining the effect of methylene blue on postoperative pain and quality of life after lumbar laminectomy and discectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients who should be operated for lumbar spinal canal stenosis or the herniation of degenerative disc in one level or multiple levels. Exclusion criteria: Patients with a history of laminectomy or diskectomy who underwent a repeated surgery and also those with infection
Age
To 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences-Zand boulevard-Shiraz
City
Shiraz
Postal code
7194815644
Approval date
2011-05-28, 1390/03/07
Ethics committee reference number
CT- 90-5571
Health conditions studied
1
Description of health condition studied
Postoperative pain improvement.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of postoperative low back pain and radicular pain
Timepoint
Before the surgical operation and 3 months after that
Method of measurement
It was measured using visual analogue scale (VAS)
Secondary outcomes
1
Description
quality of life (QoL)
Timepoint
Before the surgical operation and 3 months after that.
Method of measurement
Oswestry low back pain (OLBP) scale
Intervention groups
1
Description
Intervention group: Using methylene blue, 1cc, with 0.5% concentration after laminectomy or discectomy surgical operation for covering dura hemostasis
Category
Treatment - Drugs
2
Description
Control group: Using normal saline, 1cc after laminectomy or discectomy surgical operation for covering dura hemostasis
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faghihi Hospital
Full name of responsible person
Dr. Majid Reza Farrokhi
Street address
Shiraz Neurosciences Research Center-Chamran Hospital-Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vice-chancellor for Research Affairs of Shiraz University of Medical Sciences
Street address
Vice-chancellor for Research Affairs-Central Building of Shiraz University of Medical Sciences-Zand boulevard-Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz Neurosciences Research Center-Shiraz University of Medical Sciences
Full name of responsible person
Dr. Majid Reza Farrokhi
Position
Neurosurgeon-Fellowship of spinal surgery-director of Shiraz Neurosciences Research Center
Other areas of specialty/work
Street address
Shiraz Neurosciences Research Center-Chamran Hospital
City
Shiraz
Postal code
7194815644
Phone
+98 71 1623 4508
Fax
+98 71 1623 4508
Email
farokhim@sums.ac.ir, farrokhi_drmr@yahoo.com
Web page address
http://snrc.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faghihi Hospital-Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mehrzad Lotfi
Position
Radiologist-MRI fellowship
Other areas of specialty/work
Street address
Shiraz Neurosciences Research Center-Chamran Hospital
City
Shiraz
Postal code
7194815644
Phone
+98 71 1623 4508
Fax
+98 71 1623 4508
Email
lotfim@sums.ac.ir
Web page address
http://snrc.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz Neurosciences Research Center-Shiraz University of Medical Sciences
Full name of responsible person
Mahshid Hosseini
Position
The expert of research affairs of the center
Other areas of specialty/work
Street address
Shiraz Neurosciences Research Center-Chamran Hospital
City
Shiraz
Postal code
7194815644
Phone
+98 71 1623 4508
Fax
+98 71 1623 4508
Email
neuroscein@sums.ac.ir,hosseini_2m@yahoo.com
Web page address
http://snrc.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)