Evaluating the efficacy of laparoscopic Transversus Abdominis Block on pain and side-effects reduction in laparoscopic bariatric surgeries in Imam Khomeini hospital complex in 2020-2021
Determining the effect of laparoscopic transversus abdominis block in reducing pain and side-effects in patients undergoing laparoscopic surgery for obesity
Design
The study design will include a control group, with a parallel group of transversus abdominis block, three-sided blind, randomized on 36 patients. At first, patients undergoing laparoscopic obesity surgery will randomly be divided into two groups. Random assignment will be by Block randomization method, in which 5 pieces of paper with T and 5 with C written in them are placed in a bag and mixed, and then one piece of paper for each patient admitted to the study. According to what is written on the patient's paper, the patient will go to one of the two groups and for the next 10 patients, the papers will be returned to the bag and the procedure will be repeated. A similar anesthesia and analgesic method will be used in both groups.
Settings and conduct
This study will be performed during the years of 2020-2021 in Imam Khomeini Hospital Complex, Valiasr Hospital affiliated to Tehran University of Medical Sciences.
Patients will not know which group they are in.
The person in charge of collecting information and analyzing them will not know which group had the anesthetic injection and will only have the group title in English letters.
This randomized clinical trial study will be performed on patients undergoing laparoscopic surgery. At first, the study conditions will be fully explained to all patients and their written consent was obtained and then they entered the study.
Participants/Inclusion and exclusion criteria
Candidate patients for laparoscopic obesity surgery
Intervention groups
laparoscopic transversus abdominis block
Main outcome variables
analgesics dose
hospitalization length
pain score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201007048962N1
Registration date:2020-12-17, 1399/09/27
Registration timing:registered_while_recruiting
Last update:2020-12-17, 1399/09/27
Update count:0
Registration date
2020-12-17, 1399/09/27
Registrant information
Name
Mohammad Hadi Bahri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6612 6442
Email address
m.bahri@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of laparoscopic Transversus Abdominis Block on pain and side-effects reduction in laparoscopic bariatric surgeries in Imam Khomeini hospital complex in 2020-2021
Public title
The efficacy of laparoscopic Transversus Abdominis Block on pain and side-effects reduction of surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Laparoscopic bariatric surgery
Exclusion criteria:
No patients consent for participation in the study
Patients whose surgery becomes open or an unusual complication occurs.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
At first, patients undergoing laparoscopic obesity surgery will randomly divided into two groups. Random assignment will be by Block randomization method, in which 5 pieces of paper with T and 5 with C written on them are placed in a bag and mixed, and then one piece of paper will be allocated for each patient admitted to the study. According to what is written on the paper, the patient goes to one of the two groups and for the next 10 patients, the papers are returned to the bag and the process is repeated.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In the intervention group, a syringe containing anesthetic will be injected. In the control group, a syringe containing normal saline and free of any anesthetic will be provided to the surgeon. So that the surgeon will not know which syringe contains the anesthetic. Injections will be given to all patients.
Patients will not know which group they are in.
The person collecting the information and analyzing it will not know which group had the anesthetic injection and will only have the group title in English letters.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Imam khomeini hospital complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2017-11-04, 1396/08/13
Ethics committee reference number
IR.TUMS.IKHC.REC.1396.3867
Health conditions studied
1
Description of health condition studied
Laparoscopic bariatric surgery
ICD-10 code
Z98.84
ICD-10 code description
Bariatric surgery status
2
Description of health condition studied
postprocedural pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
pain score
Timepoint
6, 24 and 48 hours post surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The Braun Stimuplex Ainsulated needle will enter the skin from the mid-axillary line between the iliac crest and the rib margin. The needle is advanced to the distance between the internal and transverse oblique muscles of the abdomen using a laparoscopic camera and under the direct supervision of a surgeon, and then anesthesia is injected into patients in this area. In this injection, 0.5% marcain solution at the rate of 0.5 mg per kg of body weight will be used.
Category
Treatment - Devices
2
Description
Control group: The Braun Stimuplex Ainsulated needle will enter the skin from the mid-axillary line between the iliac crest and the rib margin. The needle is advanced to the distance between the internal and transverse oblique muscles of the abdomen using a laparoscopic camera and under the direct supervision of a surgeon, and then normal saline is injected into patients in this area.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Mohammadhadi Bahri
Street address
Imam Khomeini Hospital Complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 1547 7501
Email
m.bahri@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadali Sahraeian
Street address
sixth floor, Vice Chancellor for Research and Technology, University Center Organization, corner of Ghods Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8163 3686
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammadadi Bahri
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini Hospital complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
۰۲۱ ۶۱۱۹۰
Email
m.bahri@abzums.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadhadi Bahri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini Hospital complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
۰۲۱۶۱۱۹۰
Email
m.bahri@abzums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadhadi Bahri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini Hospital complex, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
۰۲۱۶۱۱۹۰
Email
m.bahri@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
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
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
The access period starts 3 months after the results are published
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The reason for the need for data to be decided
From where data/document is obtainable
Mohammadhadi Bahri
m.bahri@abzums.ac.ir
What processes are involved for a request to access data/document
An email must be sent with the reason for the need for data and their email will be answered within 2 weeks.