Comparison of classic and inguinal approach efficacy for the Obturator nerve block by nerve stimulator along with spinal anesthesia for the Trans Urethral Resection of the Bladder Tumor
Aim: Is to compare the effectiveness of classic and inguinal approach for the Obturator nerve block by nerve stimulator along with spinal anesthesia for the Trans Urethral Resection of the Bladder Tumor. Method: A number of 70 patients who have tumor on lateral wall of bladder and candidate for TURBT were admitted to the study after obtaining written consent at Imam Reza Hospital in Tabriz. Inclusion criteria were patients from 50 to 85 y/o who have been candidate for transurethral resection of the bladder tumor and Exclusion criteria were drug sensitivity; avoidance of patient; addiction; bleeding abnormality and any contraindication for Neuroaxial block. Patients randomly were divided in two groups. In group intervention 1 after infusion of 500 milliliter normal saline patients underwent to Spinal Anesthesia by Bupivacain15mg, 3 milliliter. Then patients positioned for Obturator nerve block by modified inguinal approach. Next in the sterile condition after obtaining stimulation under 0/5milivolt, Obtorator nerve was blocked by 10 milliliter of Lidocain.then patients got ready for operation. In group intervention 2 after infusion of 500 milliliter normal saline and spinal anesthesia like the above mentioned method, Obturator nerve block by classic approach. In time of block and operation other one who was not aware of protocol, records all data in point of success rate number of puncture and complication. At the end of surgery, surgeon satisfaction recorded in 4 scale rate. Then all data analyzed and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608171772N21
Registration date:2016-08-21, 1395/05/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-21, 1395/05/31
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
2015-06-05, 1394/03/15
Expected recruitment end date
2016-06-04, 1395/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of classic and inguinal approach efficacy for the Obturator nerve block by nerve stimulator along with spinal anesthesia for the Trans Urethral Resection of the Bladder Tumor
Public title
Comparison of classic and inguinal approach for the Obturator nerve block
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients from 50 to 85 y/o who have been candidate for Transurethral resection of the bladder tumor.
Exclusion criteria: drug sensitivity; avoidance of patient; addiction; bleeding abnormality; any contraindication for neuroaxial block
Age
From 50 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences University of Medical Sciences
Street address
Vice Chancellor for Research-Tabriz University of Medical Sciencest- Daneshghah Street Tabriz East Azarbaijan
City
Tabriz
Postal code
Approval date
2015-05-25, 1394/03/04
Ethics committee reference number
TBZMED.REC.1394.171
Health conditions studied
1
Description of health condition studied
Peripheral nerves of lower limb, including hip
ICD-10 code
C47.2
ICD-10 code description
Peripheral nerves of lower limb, including hip
Primary outcomes
1
Description
Number of tries to achive block
Timepoint
in time of procduore
Method of measurement
number of Puncture
Secondary outcomes
1
Description
surgen satisfaction
Timepoint
after opration
Method of measurement
good, modrate , bad, very bad (1to4)
Intervention groups
1
Description
Spinal + Obturator block inguinal approach
Category
Treatment - Drugs
2
Description
Spinal + Obturatore block classic approach
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
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 Tabriz
City
Tabriz
Postal code
Phone
+98 41 3381 8940
Fax
Email
daghamohamadi@yahoo.com
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 Tabriz
City
Tabriz
Postal code
Phone
+98 41 3381 8940
Fax
Email
daghamohamadi@yahoo.com
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 Tabriz
City
Tabriz
Postal code
Phone
+98 41 3381 8940
Fax
Email
daghamohamadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)