Effect of Transversus Abdominis Plane(TAP) Block on pain control after open Appendectomy in uncomplicated acute appendicitis
Design
This study is clinical trial and double blind. A total of 64 candidate for non-complicated appendectomy surgery in Valiasr hospital, in Arak. We will divide patients in 2 groups by simple randomization. Groups are parallel.
Settings and conduct
This study is clinical trial and double blind. A total of 64 candidate for non-complicated appendectomy surgery in Valiasr hospital, in Arak. Outcome assessor and analyzer don't aware from grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ages 18 to 65 years, no underlying disease, surgery less than one hour, no addiction, absence of connective tissue disease, absence of rheumatic disease, diagnosis of uncomplicated acute appendicitis
Exclusion criteria: patients with perforated appendicitis, ovarian cyst rupture, tubo ovarian abscess
Intervention groups
In intervention group, we place the probe in the abdominal wall on the mid-axillary line between the lower ribs and Crest Iliac before general anesthesia and under ultrasound after finding the extrinsic and intrinsic ablative muscles and the abdominal transducer nidel muscle entered the skin along the probe and 20 cc bupivacaine 0.25% injection this site and in the control group, we injected 20 cc normal saline into the petit triangle between the abdominal intrinsic muscle and the transducer abdominis muscle
Main outcome variables
Pain, mean of narcotic drug
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N135
Registration date:2020-03-06, 1398/12/16
Registration timing:registered_while_recruiting
Last update:2020-03-06, 1398/12/16
Update count:0
Registration date
2020-03-06, 1398/12/16
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-31, 1398/10/10
Expected recruitment end date
2020-12-30, 1399/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Transversus Abdominis Plane(TAP) Block on pain control after open Appendectomy in uncomplicated acute appendicitis
Public title
Effect of Transversus Abdominis Plane(TAP) Block on pain control after open Appendectomy in uncomplicated acute appendicitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 18 to 65 years
No underlying disease
Surgery less than one hour
No addiction
Absence of connective tissue disease
Absence of rheumatic disease
Diagnosis of uncomplicated acute appendicitis
Exclusion criteria:
Patients with perforated appendicitis
Ovarian cyst rupture
Tubo ovarian abscess
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in two groups A and B .
In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind). Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2019-12-29, 1398/10/08
Ethics committee reference number
IR.ARAKMU.REC.1398.271
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
Timepoint
In recovery and 2, 4, 6, 12, 24 and 48 hours after open appendectomy
Method of measurement
Visual analogue pain questionnaire
2
Description
mean of narcotic drug
Timepoint
24 hours after surgery
Method of measurement
Milligram
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In intervention group, we place the probe in the abdominal wall on the mid-axillary line between the lower ribs and Crest Iliac before general anesthesia and under ultrasound after finding the extrinsic and intrinsic ablative muscles and the abdominal transducer nidel muscle entered the skin along the probe and 20 cc bupivacaine 0.25% injection this site
Category
Treatment - Drugs
2
Description
Control group: In the control group, we injected 20 cc normal saline into the petit triangle between the abdominal intrinsic muscle and the transducer abdominis muscle
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Amirreza Naeemi
Street address
Valiasr squre, Valiasr hospital
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
naeemi@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Siamak Rakei
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 68 3222 2003
Fax
+98 86 3222 2003
Email
s.rakei@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Amirreza Naeemi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 68 3222 2003
Fax
+98 86 3222 2003
Email
naeemi@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Majid Javadi
Position
resident of surgery
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Valiasr Hospital, Valiasr square, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
7374401@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
When we publish article in journal
When the data will become available and for how long
After the article is published
To whom data/document is available
Researcher in university
Under which criteria data/document could be used
If there are additional questions
From where data/document is obtainable
Dr Amirreza Naeemi
What processes are involved for a request to access data/document
They have to write letters to the professors and the university