In this study, Patients randomly are divided into three groups & gotten general anesthesia with similar methods and medications (10micg sufentanil - 1 mg Midazolam - atracurium, isoflurane inhalation 0.6%). In group I: Bupivacaine0.25%(8 ml) + 2 ml normal saline is injected subfacial into external oblique muscle at the end of surgery . In group II: Bupivacaine0.25%(8 ml) + tramadol(100 mg =2cc) is injected similarly. .
In group III: Bupivacaine0.25%(8 ml) + 2 ml normal saline is injected subfacial into external oblique muscle at the end of surgery AND, 15 minute after end of surgery , Tramadol 100 mg is injected intramuscular also. Surgery is done by the same surgeon & technique. Then at 2, 4, 8, 12 hours after the end of surgery when hematoma or inflammation of the surgical site be ruled out, the severity of pain is checked at rest, coughing and moving states (during switching) by VAS. Also, the first analgesic request time , the total analgesic intake . level of consciousness and frequency of nausea and vomiting will be recorded. Level of consciousness is based on 3 point scale
l
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010194938N2
Registration date:2011-05-30, 1390/03/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-05-30, 1390/03/09
Registrant information
Name
HOSSEIN FARZAM
Name of organization / entity
KERMANSHAH UNIVERSITY OF MEDICAL SCIENCES
Country
Iran (Islamic Republic of)
Phone
+98 83 1835 4434
Email address
hfarzam@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Science
Expected recruitment start date
2010-03-20, 1388/12/29
Expected recruitment end date
2011-07-27, 1390/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of adding tramadol to Bupivacaine on postoperative pain in inguinal hernia surgery
Public title
Effect of adding tramadol to Bupivacaine on postoperative pain.
Purpose
Treatment
Inclusion/Exclusion criteria
In this study, the candidates for open-elective unilateral inguinal herniorrhaphy with age between 12 & 75 are enrolled if been satisfied.
Patients with ASA class more than II, have hernia recurrence, drug addiction, patients with DM (diabetes mellitus), patients who have hypersensitivity to anesthetic drugs and who develope postoperative inflammation or hematoma of surgical site are excluded.
Age
From 12 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Medical ethics committee of Kemrmanshah university of Medical Sciences
Street address
Shahid beheshti ave
City
Kermanshah
Postal code
Approval date
2010-06-15, 1389/03/25
Ethics committee reference number
7536
Health conditions studied
1
Description of health condition studied
ingunal hernia
ICD-10 code
k40-9
ICD-10 code description
Unilateral or unspecified inguinal hernia, without obstruction or gangrene
Primary outcomes
1
Description
Pain intensity
Timepoint
2, 4, 8, 12 hourse after suegery
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Level of conscious
Timepoint
2,4,8,12
Method of measurement
3 point scale
2
Description
The 1th analgesic request
Timepoint
2,4,8,12
Method of measurement
time report
3
Description
Total analgesic intake
Timepoint
2,4,8,12
Method of measurement
mg
4
Description
Nausea & Vomiting
Timepoint
2,4,8,12
Method of measurement
Observation &Question
Intervention groups
1
Description
Group 1 ; After general anesthesia (sufentanil 10 mcg, midazolam 1 mg , isoflurane o.6% , atracurium) 8 ml bupivacaine 0.25% + 2ml normal salin is injected subfacial in external oblique muscle at the end of surgery by surgeon.
Category
Treatment - Other
2
Description
After general anesthesia (sufentanil 10 mcg ,midazolam 1 mg , isoflurane o.6% , atracurium) 8 ml bupivacaine 0.25% + 2ml =100mg tramadol is injected subfacial in external oblique muscle at the end of surgery by surgeon.
Category
Treatment - Other
3
Description
After general anesthesia (sufentanil 10 mcg, midazolam 1 mg , isoflurane o.6% , atracurium) 8 ml bupivacaine 0.25% + 2ml normal saline is injected subfacial in external oblique muscle at the end of surgery by surgeon. Tramadol 100mg is injected also intramuscularly , 15 minutes after surgery.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences, Imam Reza Hospital.
Full name of responsible person
Hosein Farzam
Street address
Kermanshah University of Medical Sciences, Imam Reza Hospital. Department of anesthesiology.
City
kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Kermanshah University of Medical Sciences