Protocol summary

Summary
This study compares wound infiltration with bupivacaine and caudal block in acute postoperative pain reduction in children . the purpose of this study is if wound infiltration as effective as caudal approch in reducing acute postoperative pain, it can be a safe , fast alternative technique for caudal block . this is a double blinded , single centered , randomised clinical trial controlled with standard group without placebo , and , patients and their parents are not aware of groups. papulation of study consist of fifty-five , 2-8 years old , ASA class I-II patients undergoing elective lower abdominal surgery . exclusive criteria included urgent surgery , sensitivity to local anesthetics , G6PD deficiency , coagulative disorder , localized infection , parents refusal and pre-existing neurologic disorder. after induction of general anesthesia , at the end of surgery , patients randomly receive one of caudal block or wound infiltration interventions , and then informations about postoperative pain intensity, parental satisfaction, duration of analgesia provided by each technique , and the time of first urination and bowel activity record 1, 6 , 12, 24 hour after operation and analyse statistically.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201307308391N2
Registration date: 2013-08-11, 1392/05/20
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-08-11, 1392/05/20
Registrant information
Name
Mehrsima Abdollahzadeh
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 2021
Email address
abdollahzadeh@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
guilan university of medical sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-08-22, 1393/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of effect of caudal block and wound infiltration with bupivacaine in acute postoperative pain control in children after elective lower abdominal surgery with general anesthesia
Public title
Acute abdominal Postoperative Pain Control in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : 2-8 years old patient with ASA class I-II under elective lower abdominal surgery (aug 2013 - aug 2014) Exclusion criteria : ASA class III- IV , urgent surgery , sensitivity to local anesthetics , G6PD deficiency , coagulation disorder , localized infection , parents refusal, pre-existing neurologic disorder
Age
From 2 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 55
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
Guilan University of Medical Sciences
Street address
Azodi street
City
Rasht
Postal code
4193833697
Approval date
2013-07-29, 1392/05/07
Ethics committee reference number
1920141905

Health conditions studied

1

Description of health condition studied
acute postoperative pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain

Primary outcomes

1

Description
acute postoperative pain
Timepoint
1-6-12-24 hour after procedure
Method of measurement
modified objective pediatric pain scale(0-10)

Secondary outcomes

1

Description
Parents satisfaction
Timepoint
1-6-12-24 hour after procedure
Method of measurement
satisfaction score(0-3) {0=not at all satisfied, 1=not satisfied, 2= partially satisfied, 3= satisfied}

2

Description
amount of rectally received acetaminophen
Timepoint
1,6,12,24 hour after surgery
Method of measurement
total dosage(mg) and the number of times received rectal acetaminophen

3

Description
duration of analgesia provided by technique
Timepoint
hour/min after surgery
Method of measurement
interval between administration of the first dose of rectal acetaminophen and prucedure

4

Description
urine retention - bowel activity
Timepoint
1,6,12,24 hour after surgery
Method of measurement
time intrval of first urination / bowel activity from prucedure

Intervention groups

1

Description
intervention group : wound infiltration with 0/5 ml/kg bupivacaine 0/25% into the edges of the wound after fascial closure.
Category
Prevention

2

Description
control group : caudal analgesia with 1ml/kg bupivacaine 0/25%
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Mehrsima abdollahzadeh
Street address
Namjoo Street
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Abdolrasol Sobhani
Street address
Emam Khomeini Blv.Top of the IRAN radiator Co.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Mehrsima Abdollahzadeh
Position
Anesthesiologist\assistant proffesor
Other areas of specialty/work
Street address
Namjoo street,Alzahra hospital
City
Rasht
Postal code
Phone
+98 13 1321 0434
Fax
+98 13 1322 8724
Email
vbuh.research@gmail.com,mehrsima@yahoo.com,ARC@gums.ac.ir
Web page address
www.gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Mehrsima Abdollahzadeh
Position
Anesthesiologist\Assistant Proffesor
Other areas of specialty/work
Street address
Namjoo St.,Alzahra hospital
City
Rasht
Postal code
Phone
+98 13 1321 0434
Fax
+98 13 1324 5132
Email
mehrsima49@yahoo.com, ARC@gums.ac.ir,vbuh.research@gmail.com
Web page address
www.gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Mehrsiam Abdoollah zadeh
Position
Anesthesiologist\Assistant Professor
Other areas of specialty/work
Street address
Alzahra hospital
City
rasht
Postal code
Phone
+98 13 1321 0434
Fax
+98 13 1324 5132
Email
mehrsima49@yahoo.com,vbuh.research@gmail.com,ARC@gums.ac.ir
Web page address
www.gums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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