Evaluation the Effectiveness of Transversus Abdominis Plane (TAP) Block with Bupivacaine for Pain Control after Appendectomy in Children
Inclusion criteria:
1) Children with ASA class 1 or 2 ratings
2) Children between the ages of 4-16 years.
3) Appendectomy candidates
Exclusion criteria:
1) Obese patients BMI more than 30
2) Patients with perforated appendicitis
3) Other surgical patients with appendicitis
After obtaining informed consent from parents 40 children with age range of 4 -16 years in grades I and II using ASA rating of who were candidate appendectomy coming to Tabriz Children Hospital during 1393-1392 were randomly divided into two groups. Twenty patients in the Tap block group and 20 patients in the control group will be evaluated. Both groups will received general anesthesia. 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 . If the pain score greater than or equal to 4, intravenous acetaminophen 10mg / kg , And if the pain score will be less than 4 oral, acetaminophen will be prescribed.
In addition, 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. By doing this block is expected to reduce the incidence and severity of pain after appendectomy in children and the need for analgesics.
Type of study:
A double-blind randomized clinical trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201503024041N11
Registration date:2015-04-07, 1394/01/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-07, 1394/01/18
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
2014-01-21, 1392/11/01
Expected recruitment end date
2014-11-21, 1393/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Effectiveness of Transversus Abdominis Plane (TAP) Block with Bupivacaine for Pain Control after Appendectomy in Children
Public title
Effect of injection analgesic drug in abdomen wall for pain after appendix surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :children with ASA class 1,2 ,children with age between 4-16 years old ,patients candidated for appandectomy
Exclusion criteria:
Obese patients BMI more than 30;Patients with perforated appendicitis;Other surgical patients with appendicitis;Sensitivity to local anesthetics;Patients with organ dysfunction;Patients with psychological dysfunction;Patients with chronic use of pain medications.
Age
From 4 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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
Golghasht-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
2013-10-21, 1392/07/29
Ethics committee reference number
92110
Health conditions studied
1
Description of health condition studied
Appendicitis
ICD-10 code
K35.8
ICD-10 code description
Acute appendicitis, other and unspecified
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 two hours to 8 hours, then every 4 hours for 24 hours
Method of measurement
by Researcher postoperative
Intervention groups
1
Description
In the control group after general anesthesia
will not have any intervention.
Category
Treatment - Drugs
2
Description
In the intervention group after general anesthesia patient will be received TAP Block with Bupivacaine 0.25% ,(0.25 ml/kg) and adrenaline 1/200000 in Petit triangle.
Category
Treatment - Drugs
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 Seyedhejazi pediatric anesthesiologist
Street address
Tabriz-Sheshgelan Street- Hospital Children's Center
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Hasan Soleimanpour
Street address
Golgasht Ave- Tabriz University of Medical Sciences
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
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 Sciences
Full name of responsible person
Dr.Samira Motarabesoon
Position
Assistant of Anesthesiology
Other areas of specialty/work
Street address
Tabriz-University of Medical Sciences - Department of Anesthesiology
City
Tabriz
Postal code
Phone
+98 41 3385 7695
Fax
Email
samira.mt58@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mahin Seyed-hejazi
Position
Anesthesiologist-Professor
Other areas of specialty/work
Street address
Tabriz-Sheshgelan street - Children's Hospital of Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3477 3957
Fax
Email
seidhejazie@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
mahin seyedhejazi
Position
professor
Other areas of specialty/work
Street address
Tabriz children hospital
City
Postal code
Phone
+98 41 3477 3957
Fax
Email
seidhejazie@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)