The aim of this study is to compare the effect of peritoneal infiltration and subcutaneous infiltration of Bupivacaine 0.5 % on postoperative pain in patients with acute Appendicitis. In this double-blind clinical trial, 126 patients aged 15-45years, with acute Appendicitis in Kashasn Shaheed Beheshti Hospital will be recruited. Patient will be randomly allocated into three groups. In group A, peritoneal infiltration of 0.5% Bupivacaine and in group B, subcutaneous infiltration of 0.5% Bupivacaine will be performed. Group C will have no injection. Postoperative pain will be evaluated using a self-administered visual analogue scale (VAS) as primary outcome measure. The usage of Pethedine in 24 hours after operation will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109067491N1
Registration date:2011-10-16, 1390/07/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-16, 1390/07/24
Registrant information
Name
Mehdi Zanganeh
Name of organization / entity
Kasahan
Country
Iran (Islamic Republic of)
Phone
+98 36 1562 0390
Email address
zangane_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan Univercity of Medical Sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2010-11-20, 1389/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of intraperitoneal and subcutaneous injection of Bupivacaine on postoperative pain of appendicitis
Public title
Comparing the effect of peritoneal infiltration and subcutaneous infiltration of Bupivacaine 0.5 % on postoperative pain in patients with acute Appendicitis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age between 15-45 years; acute appendicitis. Exclusion criteria: addiction; complicated appendicitis (perforation, abscess, gangrene); patient with psychology disorders; diabetes and history of chronic diseases.
Age
From 15 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
5th Km of Ghotbe Ravandi Blvd.
City
Kashan
Postal code
8814187159
Approval date
2010-06-19, 1389/03/29
Ethics committee reference number
62/1/8/29/پ
Health conditions studied
1
Description of health condition studied
appendicitis
ICD-10 code
K35
ICD-10 code description
Acute appendicitis
Primary outcomes
1
Description
pain after operaion
Timepoint
6, 12 and 24 hours after operaion
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
pethedin dosage
Timepoint
24 haur after operation
Method of measurement
number of adminstrated pethedin dosage
Intervention groups
1
Description
Group A: peritoneal infiltration of Bupivacaine 5% ( 1mg/kg)
Category
Treatment - Drugs
2
Description
Group B: subcutaneous infiltration of Bupivacaine 5% ( 1mg/kg)
Category
Treatment - Drugs
3
Description
Group C: without any injection
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Dr.Mehdi Zanghaneh
Street address
5th Km of Ghotbe Ravandi Blvd.
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
5th Kilometer Ghotbe Ravandi Blvd.
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan Univercity of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Fazel
Position
Anesthesiologist
Other areas of specialty/work
Street address
Beheshti Hospital, 5th Kilometer Ghotbe Ravandi Blvd.
City
Kashan
Postal code
8715988141
Phone
+98 36 1555 2999
Fax
+98 36 1557 5057
Email
Mdfazel@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan Univercity of Medical Sciences
Full name of responsible person
Dr.Mehdi Zanghaneh
Position
Assistant General Surgery
Other areas of specialty/work
Street address
Shaheed Beheshti Hospital, Kashan Univercity of Medical Sciences
City
Kashan
Postal code
8715988141
Phone
+98 36 1562 0390
Fax
+98 36 1557 5057
Email
Mehdi_zn56@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan Univercity of Medical Sciences
Full name of responsible person
Dr. Mehdi Zanghaneh
Position
Assistant General Surgery
Other areas of specialty/work
Street address
City
Kashan
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)