The purpose of this study is comparison effect of different doses of fentanyl on epidural block quality and complications. In this randomized, double blind clinical trial, a number of sixty patients between thirty to seventy years old enrolled in study. Inclusion criteria: candidate for elective inguinal hernia surgery; lack of severe systemic and mental disease; consent to take part in the study and exclusion criteria: history of drug allergy; opiate use; sedative use. Three groups A, B and C were selected. These groups were unified based on age and sex. The group A received block with Epinephrine and Lidocaine, groups B and C except for same amount of Epinephrine and Lidocaine, orderly received 25µg and 50µg Fentanyl. In each group patients evaluate for hemodynamic variable, block quality and analgesic needs. Then data’s record and statistically analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502171617N10
Registration date:2015-05-13, 1394/02/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-13, 1394/02/23
Registrant information
Name
Mansour Choubsaz
Name of organization / entity
Imam Reza Hospital
Country
Iran (Islamic Republic of)
Phone
+98 83 1724 6708
Email address
mchoubsaz@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2015-07-20, 1394/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of different-doses fentanyl effects on epidural block quality in patients undergoing elective inguinal hernia surgery
Public title
different-doses fentanyl effects on epidural block quality in hernioraphy surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: candidate for elective hernioraphy surgery; lack of severe systemic and mental disease; consent to participate in the study Exclusion criteria: history of drug allergy; opiate use; sedative use
Age
From 30 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethic Committee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6718938179
Approval date
2014-07-22, 1393/04/31
Ethics committee reference number
17181
Health conditions studied
1
Description of health condition studied
inguinal hernia
ICD-10 code
K40.9
ICD-10 code description
Inguinal hernia (unilateral) NOS
Primary outcomes
1
Description
Pain
Timepoint
0,1,4 hours
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Block level
Timepoint
0,1,4 hours
Method of measurement
Dermatom
Intervention groups
1
Description
Adding 25 micro gram fentanyl to lidocaine and epinephrine
Category
Treatment - Drugs
2
Description
adding 50 micro gram fentanyl to lidocaine and epinephrine
Category
Treatment - Drugs
3
Description
lidocaine and epinephrine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Hosein Karim
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Imam Reza Hospital
Full name of responsible person
Fatemeh Aalinezhad
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Kermanshah
Postal code
6718938179
Phone
+98 83 3724 6708
Fax
+98 83 3724 4969
Email
mchoobsaz@kums.ac.ir
Web page address
kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
khosro farhadi
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6718038179
Phone
+98 83 3724 6708
Fax
+98 83 3724 4969
Email
mchoobsaz@kums.ac.ir
Web page address
kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mansour Choubsaz
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6718938179
Phone
+98 83 3724 6708
Fax
+98 83 3724 4969
Email
mchoobsaz@kums.ac.ir
Web page address
kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)