Comparative study of the effect of rupivacaine 0.2 and bupivacaine 0.2 in the transversus abdominis plane block (TAP) under ultrasound guidance in management of acute pain after open appendectomy ( Clinical Trial )
Comparison of the effect of rupivacaine 0.2% and bupivacaine 0.2% in ultrasonically guided transverse abdominal muscle block in the control of acute pain after open appendectomy
Design
A randomized double-blind clinical trial, two groups of 26; intervention: TAP block with rupivacaine 0.2% and control TAP block with bupivacaine 0.2%.randomized using the random numbers table:
Settings and conduct
Candidates for open appendectomy referred to Shahid Madani Hospital in Karaj will be randomly divided into two groups of 26 randomly in one of the intervention / control groups.
Participants/Inclusion and exclusion criteria
This study will be performed on patients with open appendectomy referred to Shahid Madani Hospital in Karaj in 2021-2022 and patients with coagulation disorders, chronic abdominal pain and substance and alcohol abuse will not be included in the study.
Intervention groups
Intervention group: These patients receive 20 ml of rupivacaine 0.2% and develop TAP block under ultrasound guide.
Control group: These patients receive 20 ml of bupivacaine 0.2% and develop TAP block under ultrasound guide.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211112053042N1
Registration date:2021-11-23, 1400/09/02
Registration timing:prospective
Last update:2021-11-23, 1400/09/02
Update count:0
Registration date
2021-11-23, 1400/09/02
Registrant information
Name
Mohammad Hossein Delshad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3350 2347
Email address
m.delshad@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-05, 1400/09/14
Expected recruitment end date
2022-01-19, 1400/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of rupivacaine 0.2 and bupivacaine 0.2 in the transversus abdominis plane block (TAP) under ultrasound guidance in management of acute pain after open appendectomy ( Clinical Trial )
Public title
Comparison of the effect of rupivacaine 0.2 and bupivacaine 0.2 in the transversus abdominis plane block (TAP) under ultrasound guidance in management of acute pain after open appendectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years
Patients with consent to participate in the project
Exclusion criteria:
Coagulation disorders
Chronic abdominal pain
Substance and alcohol abuse
Dissatisfaction with participating in the project
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups based on a table of random numbers. Random number table is a set of numbers that are produced without a specific pattern or order and in a completely random manner and become a table. In order to use a random number table, the researcher must first predetermine the table to read the numbers (for example, up, down, left, or right). Individual for the control group). The researcher then touches one of the numbers and moves in one of the predetermined directions and records the numbers and assigns them to different groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients (intervention or control) will receive encoded sealed envelopes. The coding will be done by one of the project partners and the doctor, the evaluator and the patient will be blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
second floor, Deputy of Research and Technology, Saffarian Alley, 45 meters from Golshahr, Karaj.
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2021-08-24, 1400/06/02
Ethics committee reference number
IR.ABZUMS.REC.1400.180
Health conditions studied
1
Description of health condition studied
Acute pain after open appendectomy
ICD-10 code
G89. 18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Intensity of pain
Timepoint
2, 4, 6, 8, 12, 24 and 48 hours after transverse abdominal muscle block
Method of measurement
Ask the patient based on the visual analog scale (0= No pain, 1-3=Mild, 4-7= Moderate, 8-10=Severe)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: These patients will receive 20 ml of rupivacaine 0.2% and develop TAP block under ultrasound guide.
Category
Prevention
2
Description
Control group: These patients will receive 20 ml of bupivacaine 0.2% and develop TAP block under ultrasound guide.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani Hospital
Full name of responsible person
Mohammad Hossein Delshad MD.
Street address
Shahid Madani Square, Jahanshahr, Karaj
City
Karaj
Province
Alborz
Postal code
31437 44693
Phone
+98 26 3442 7001
Email
m.delshad@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Hatam Godini P.H.D
Street address
Saffarian alley, 45 meters from Golshahr, Karaj
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
h.godini@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Hossein Delshad MD.
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Arghavan Gharbi, 45 meters from Golshahr Street, Karaj, Alborz Province
City
Karaj
Province
Alborz
Postal code
3198683639
Phone
+98 26 3350 2347
Email
m.delshad@abzums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Hossein Delshad MD.
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Arghavan Gharbi, 45 meters from Golshahr Street, Karaj, Alborz Province
City
Karaj
Province
Alborz
Postal code
3198683639
Phone
+98 26 3350 2347
Email
m.delshad@abzums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Hossein Delshad MD.
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Arghavan Gharbi, 45 meters from Golshahr Street, Karaj, Alborz Province
City
Karaj
Province
Alborz
Postal code
3198683639
Phone
+98 26 3350 2347
Email
m.delshad@abzums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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
All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
Access period starts 6 months after the results are published.
To whom data/document is available
Research centers and faculty members
Under which criteria data/document could be used
At the request of the researcher and faculty members
From where data/document is obtainable
Send email to the scientific respondent
What processes are involved for a request to access data/document
Within two months from the time of requesting and sending the email, the documents will be sent to the mentioned people