Evaluation of the efficacy of ropivacaine in transverse abdominis plane (TAP) block for pain in pediatrics undergoing appendectomy : a controlled randomized trial
Investigating the effect of Ropivacaine in TAP block in reducing analgesic consumption and pain reduction after appendectomy in children
Design
The study of a clinical trial has a control group with parallel, double-blind, randomized, block-based groups on 50 patients.
Candidates in this study were randomly divided into 2 groups in the form of blocks of 4 with equal volume. First 12 blocks of 4 are prepared (Excel software is used to prepare random arrangements inside each block) and then these blocks are arranged randomly and people are assigned to two groups according to A and B are given. In order to hide the allocation process, closed envelopes will be used.
Settings and conduct
Patients who candidate for appendectomy at AKBAR hospital after parents consent will participated in study. Data analysts and patients were blinded to which group they entered.To hide the allocation process, closed envelopes will be used.
Participants/Inclusion and exclusion criteria
Age 4 -16 years
Patient who candidate for appendectomy
Intervention groups
All patients are first administered intravenous ketamine at a dose of 1.5 milligrams per kilogram in the waiting room before being transferred to the operating room. Patients receive sevoflurane 6% along with remifentanil at a dose of 0.6 mic/kg and rocuronium at a dose of 0.6 mg/kg intravenously, prior to endotracheal intubation. General anesthesia is maintained with the minimal alveolar concentration of sevoflurane and an infusion of remifentanil at a rate of 0.05 mic/kg/min.
In the intervention group, TAP block is performed using 0.2% ropivacaine at a dose of 0.5 milliliters per kilogram, guided by ultrasound at the end of the surgery and before the patient awakens from general anesthesia. All standard pain management protocols are uniformly applied to both groups postoperatively.
Main outcome variables
Pain after surgery
Amount of morphine consumed
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230315057725N1
Registration date:2023-09-05, 1402/06/14
Registration timing:registered_while_recruiting
Last update:2023-09-05, 1402/06/14
Update count:0
Registration date
2023-09-05, 1402/06/14
Registrant information
Name
Mohadeseh Sabour Darbandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3864 8137
Email address
sabourm991@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of ropivacaine in transverse abdominis plane (TAP) block for pain in pediatrics undergoing appendectomy : a controlled randomized trial
Public title
Evaluation of the efficacy of transverse abdominis plane (TAP) block for pain in pediatrics undergoing appendectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient who candidate for appendectomy
Age between 4 to 16 years old
Obtaining informed consent from parents to participate the study
Exclusion criteria:
Having other comorbidities
History of previous surgery
Candidate for performing several operations at the same time
Abnormal laboratory data
High body mass index
Perforated appendicitis
Allergic reaction to local anesthetics
Age
From 4 years old to 16 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method is used. Candidates in this study were randomly divided into 2 groups in the form of blocks of 4 with equal volume. For this purpose, first 12 blocks of 4 are prepared (Excel software is used to prepare random arrangements inside each block) and then these blocks are arranged randomly and people are assigned to two groups according to A and B are given This action continues continuously until the sample volume is completed. Also, in order to hide the allocation process, closed envelopes will be used
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants enter the study after obtaining consent and receiving explanations from two study groups. However, the decision about which group they will participate in will be blinded. Additionally, the assessors who evaluate postoperative pain at specified time intervals will be blinded to whether the patient has been enrolled in either of the groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Medicine, Mashhad University of Medical Sciences (Research Ethics Committee)
Street address
No 63, 14 Daneshjou Ave, Daneshjou Boulevar, Mashhadd
City
Mashhad
Province
Razavi Khorasan
Postal code
9188961441
Approval date
2023-04-18, 1402/01/29
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.035
Health conditions studied
1
Description of health condition studied
Pain after appendectomy
ICD-10 code
Y48.02
ICD-10 code description
local anesthetics
Primary outcomes
1
Description
Pain after surgery
Timepoint
Every 4 hours till 12 hours after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
The total amount of analgesics consumption
Timepoint
12 hours after surgery
Method of measurement
The total dose of morphine consumption
Intervention groups
1
Description
All patients are first administered intravenous ketamine at a dose of 1.5 milligrams per kilogram in the waiting room to achieve tranquility before being transferred to the operating room. Subsequently, patients receive sevoflurane 6% along with remifentanil at a dose of 0.6 micrograms per kilogram and rocuronium at a dose of 0.6 milligrams per kilogram intravenously, prior to endotracheal intubation. General anesthesia is maintained with the minimal alveolar concentration of sevoflurane and an infusion of remifentanil at a rate of 0.05 micrograms per kilogram per minute.In the intervention group, tap block is performed using 0.2% ropivacaine at a dose of 0.5 milliliters per kilogram, guided by ultrasound at the end of the surgery and before the patient awakens from general anesthesia. All standard pain management protocols are uniformly applied to both groups postoperatively.
Category
Treatment - Other
2
Description
All patients are first administered intravenous ketamine at a dose of 1.5 milligrams per kilogram in the preoperative waiting room to achieve tranquility before being transferred to the operating room. Subsequently, patients receive sevoflurane 6% along with remifentanil at a dose of 0.6 micrograms per kilogram and rocuronium at a dose of 0.6 milligrams per kilogram intravenously, prior to endotracheal intubation. General anesthesia is maintained with the minimal alveolar concentration of sevoflurane and an infusion of remifentanil at a rate of 0.05 micrograms per kilogram per minute.. It's important to note that all standard pain management protocols are uniformly applied to both groups postoperatively.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
َAkbar hospital
Full name of responsible person
Mohadeseh Sabour Darbandi
Street address
No 63, 14 Daneshjou Ave, Daneshjou Boulevar, Mashhadd
City
Mashhad
Province
Razavi Khorasan
Postal code
9188961441
Phone
+98 51 3864 8137
Email
sabourm991@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ebrahim Golmakani
Street address
No 63, 14 Daneshjou Ave, Daneshjou Boulevar, Mashhadd
City
Mashhad
Province
Razavi Khorasan
Postal code
9188961441
Phone
+98 51 3864 8137
Email
sabourm991@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohadeseh Sabour Darbandi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 63, Daneshjou 14,mashhad,iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9188961441
Phone
+98 51 3864 8137
Fax
Email
sabourm991@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohadeseh Sabour Darbandi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 63, Daneshjou 14,mashhad,iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9188961441
Phone
+98 51 3864 8137
Fax
Email
sabourm991@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohadeseh Sabour Darbandi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 63, Daneshjou 14,mashhad,iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9188961441
Phone
+98 51 3864 8137
Fax
Email
sabourm991@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available