The aim of this single blind randomized clinical trial is comparing general anesthesia with general anesthesia combined with epidural anesthesia regarding bleeding and pain after the operation. In this study, 60 patients who are eligible for study inclusion and exclusion criteria allocate in one of the intervention or control groups. Intervention group patients in the supine position will be anesthetized by epidural anesthesia then placed in a supine position and anesthetized genarally. In the control group patients will only be anesthetized genarally in the same way that the Intervention group will be performed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109173773N5
Registration date:2012-01-05, 1390/10/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-01-05, 1390/10/15
Registrant information
Name
Farsad Imani
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 4469 0816
Email address
imanifar@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of General Anesthesia and Combined General Epidural Anesthesia regarding bleeding and post-operative pain after lumbar discectomy surgeries
Public title
Comparison of General Anesthesia and Combined General Epidural Anesthesia regarding bleeding and post-operative pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing discectomy operation for disc herniation at 1-2 levels. Exclusion criteria: A.S.A class more than 3, Multilevel spinal stenosis (more 2 level), coagulopathy, lumbar localized infection, lumbar region abnormalities, and patients who have contraindications for regional anesthesia.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences-Research administration
Street address
Keshavarz Bv. Ghods st. Cross
City
Tehran
Postal code
Approval date
2011-08-14, 1390/05/23
Ethics committee reference number
807/130/د/90
Health conditions studied
1
Description of health condition studied
Lumbar post-operative pain
ICD-10 code
T02.7
ICD-10 code description
Fractures involving thorax with lower back and pelvis with limbs
2
Description of health condition studied
bleeding during lumbar operation
ICD-10 code
I95.9
ICD-10 code description
Hypotension, unspecified
Primary outcomes
1
Description
Bleeding
Timepoint
during operation
Method of measurement
milliliter
2
Description
Pain
Timepoint
At 5, 10, 15, 20 minutes at recovery & 4, 10, 24 hour after operation at ward
Method of measurement
Visual Analogue Scale = VAS
Secondary outcomes
1
Description
Blood Hb
Timepoint
afetr operation
Method of measurement
gr%
2
Description
Mean Blood Pressure
Timepoint
During operation
Method of measurement
Monitoring Devices
3
Description
Heart Rate
Timepoint
During operation
Method of measurement
Monitoring devices
4
Description
Morphine
Timepoint
During 1 day after operation
Method of measurement
Milligram
Intervention groups
1
Description
Intervention group first receive epidural anesthesia in sitting position (by number 9 catheter and 10 cc Lidocaine 1% +10 cc Bupivacaine 0.5% + 1 cc Fentanil) then in supine position they will be anesthetized generally. Introperative bleeding volume, hemodynamic condition = mean blood pressure, heart rate, and first post operative pain scale based on VAS & amount of morphine administration will be documented.
Category
Treatment - Drugs
2
Description
Control group will only be anesthetized generally. Introperative bleeding volume, hemodynamic condition = mean blood pressure, heart rate, and first post operative pain scale based on VAS & amount of morphine administration will be documented.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Mohammadreza Khajavi M.D.
Street address
Imam Khomeini St. Hasan'abad Sq.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences, Medical Faculty
Full name of responsible person
Mohammadreza Khajavi
Street address
Keshavarz Bv. Ghods st. Cross
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences, Medical Faculty
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Tehran University of Medical Sciences, Medical Faculty
Full name of responsible person
Mohammadreza Khajavi M.D.
Street address
Keshavarz Bv. Ghods st. Cross
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences, Medical Faculty
Proportion provided by this source
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
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Khajavi M.D.
Position
Associatr Professor
Other areas of specialty/work
Street address
Keshavarz Bv. Ghods st. Cross
City
Tehran
Postal code
Phone
+98 21 63120
Fax
Email
khajavim@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences, Medical Faculty
Full name of responsible person
Mohammad Amir Asadian M.D.
Position
Anesthesiology assistant
Other areas of specialty/work
Street address
Imam Khomeini St. Hasan'abad Sq.
City
Tehran
Postal code
1136746911
Phone
+98 21 63120
Fax
Email
ehsani@itc.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences, Medical Faculty
Full name of responsible person
Farsad Imani M.D.
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Khomeini St. Hasan'abad Sq.
City
Tehran
Postal code
1136746911
Phone
+98 21 63120
Fax
Email
imanifar@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)