After obtaining informed consent from parents 72 children with age range of 1-12years in grades 1and 2 using ASA rating of who were candidate lower abdominal surgery coming to Tabriz Children Hospital during 1395-1396 were randomly divided into two groups.Thirty six patient in incisional injection group and 36 patients in the control group.both groups will received general anesthesia and airway management with the same method.In the first group after surgery before closure 0.5ml/kg bupivacaine 0.125%maximum 20ml will be injected into the fascia layer and in other group injection will not be used.postoperative pain score will be measured based on VAS(visual analog scale)in recovery room and then every 2 hours up to 8 hours ,and then every 4 hours up to 24 hours.the first request for analgesia, the total dose of pain medication after surgery ,the incidence and severity of postoperative complications between the two groups will be recorded
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201503024041N12
Registration date:2017-04-03, 1396/01/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-03, 1396/01/14
Registrant information
Name
Mahin Seyedhejazi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 2252
Email address
seidhejazie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz university of medical sciences vice chancellor for research and technology
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of incisional injection of bupivacane for pain control after pediatric lower abdominal surgery
Public title
Effect of injection of local anesthetic into the pediatric surgical site
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:1)children with age between 1-12 years with ASA class 1,2. 2)patients candidates of lower abdominal surgery
Exclusion criteria:1)urgent surgery.2)concurrent surgery.3)hypersensivity to local anesthetics4)organ dysfunction.5)psychiatric dysfunction.6)chronic use of analgesics
Age
From 1 year old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
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
Tabriz university of medical sciences vice chancellor for research and technology
Street address
Golgasht-st.Tabriz-Tabriz university of medical sciences,central building no.2-Third floor-vice chancellor research and technology
City
Tabriz
Postal code
51665-118
Approval date
2016-11-14, 1395/08/24
Ethics committee reference number
iR.TBZMED.REC.1395.883
Health conditions studied
1
Description of health condition studied
injection of local anesthetic into surgical site of inguinal hernia
ICD-10 code
N43.3 k4
ICD-10 code description
...,Hydrocele,inguinal hernia
Primary outcomes
1
Description
incisional pain
Timepoint
immediately after the intervention
Method of measurement
VAS score Questionnaire
Secondary outcomes
1
Description
The need for analgesic
Timepoint
Every 2 hours to 8 hours, then every 4 hours for 24 hours
Method of measurement
person other than researcher
Intervention groups
1
Description
intervention group: after end of surgery before closure 0.5ml/kg bupivacaine 0.125%(MYLAN company) will be injected into the fascia.
Category
Treatment - Drugs
2
Description
control group: without injection after termination of surgery.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Children`s hospital of tabriz university of medical sciences
Full name of responsible person
Dr Mahin Seidhejazi
Street address
Tabriz-Sheshgelan st.hospital children`s center
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz university of medical sciences vice chancellor for research and technology
Full name of responsible person
Dr Hasan Soleimanpour
Street address
Golgasht-st.Tabriz- Tabriz university of medical siences,central building no.2-third floor-vice chancellor research and technology
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz university of medical sciences vice chancellor for research and technology
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
Tabriz university of medical science
Full name of responsible person
Dr Sahar Sadeghi
Position
Assistant of anesthesiology
Other areas of specialty/work
Street address
Tabriz-university of mrdical science-department of anesthesiology
City
Tabriz
Postal code
00
Phone
00
Fax
Email
dandelion1363@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical science
Full name of responsible person
Dr Mahin Seidhejazi
Position
Anesthesiologist-professor
Other areas of specialty/work
Street address
Tabriz -Sheshgelan st.children`s hospital of tabriz university of medical science
City
Tabriz
Postal code
00
Phone
+98 41 3526 2255
Fax
Email
seidhezazie@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz university of medical science
Full name of responsible person
Dr Mahin Seidhejazi
Position
professor-anesthesiologist
Other areas of specialty/work
Street address
Tabriz children hospital
City
Tabriz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)