Comparative study of the effect of TAP (Transverse Abdominis Plane) block and anesthesia infiltration site on postoperative pain in patients with unilateral inguinal hernia repair surgery
Comparison of Transverse Abdominis Plane block and local infiltration on postoperative pain in patients undergoing unilateral inguinal hernia repair surgery in Shahid Beheshti Hospital in Kashan in 2021
Design
In this randomized interventional one-side blinded IRCT, patients with unilateral inguinal hernia with the age of 18-70 years who are admitted to Shahid Beheshti Hospital to perform inguinal hernia repair in 2021 are included. Randomization will be done by picking a paper by an operation technologist via close eyes. After the termination of the surgery and before wakening the patient up one of the below interventions for the post operative pain management will be done. Transverse Abdominis Plane block or local anesthetics infiltration or no intervention.
Settings and conduct
Patients with unilateral inguinal hernia with the age of 18-70 years who refer to Shahid Beheshti Hospital in Kashan in 1400 to perform inguinal hernia repair will be included in the study. after the end of the operation for the postoperative pain management one of the below interventions will be done , Transverse Abdominis Plane block , local infiltration or no intervention for the control group
Participants/Inclusion and exclusion criteria
Patients with unilateral inguinal hernia with the age of 18-70 years who refer to Shahid Beheshti Hospital in Kashan in 1400.
• No history of drug addiction
• Patients with ASA grade one and two
Do not take any pain medications 24 hours before surgery
No history of allergy to bupivacaine
• Complete informed consent
Intervention groups
group1, using 20 cc of bupivacaine 0.25% for the anesthesia
Group 2, transabdominal anesthesia between the the abdominal muscles via ultrasound technique. Injection of 20 cc bupivacaine 0.25%
Group3, not each of above interventions
Main outcome variables
Pain severity score
nausea and vomiting
Opioid use 24 hours after surgery
Intervention group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191103045320N2
Registration date:2022-12-21, 1401/09/30
Registration timing:retrospective
Last update:2022-12-21, 1401/09/30
Update count:0
Registration date
2022-12-21, 1401/09/30
Registrant information
Name
Mohammad Shabani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4422 0704
Email address
mohammadshabaniii77@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-11, 1400/11/22
Expected recruitment end date
2022-08-27, 1401/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of TAP (Transverse Abdominis Plane) block and anesthesia infiltration site on postoperative pain in patients with unilateral inguinal hernia repair surgery
Public title
Comparative study of the effect of TAP (Transverse Abdominis Plane) block and anesthesia infiltration site on postoperative pain in patients with unilateral inguinal hernia repair surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
No history of drug addiction
Patients with ASA grade one and two
Do not take any pain medications 24 hours before surgery
عدم سابقه حساسیت به بوپی واکائین
Complete informed consent
Exclusion criteria:
Age
From 18 years old to 70 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
63
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method
Randomization will be done by picking a piece of paper inside a glass by an operating room technologist with closed eyes , on the one third of the papers it is written that "Transverse Abdominis Plane block" and on the other one third it is written "local infiltration" , and on the rest of the one third it is written "control"
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
Ethics committee of the Kashan University of Medical Sciences
Street address
Qutb Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2021-10-27, 1400/08/05
Ethics committee reference number
IR.KAUMS.REC.1400.046
Health conditions studied
1
Description of health condition studied
Postoperative pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Score of severity of the post operation pain
Timepoint
Before surgery, after admission to the recovery ward, 15 minutes after staying in the recovery ward, after admission to the surgery ward
Method of measurement
Pain is a subjective outcome, so, we ask the patients about the pain and they will score from 1 to 10 (10 = most severe). Other indicators of the pain such as hypertension, tachycardia, ECG changes, sweating, lacrimation and mydriasis will be considered.
2
Description
Nausea and vomiting in the post operative period setting
Timepoint
Before surgery, after admission to the recovery ward, 15 minutes after staying in the recovery ward, after admission to the surgery ward
Method of measurement
Asking from the patient, observing patient situation
3
Description
Opioid consumption in the 24 hours after operation
Timepoint
Before surgery, after admission to the recovery ward, 15 minutes after staying in the recovery ward, after admission to the surgery ward
Method of measurement
Recording of the total opioid consumption in the patient document and in a piece of paper near the head of the patient
Secondary outcomes
1
Description
Postoperative pain (visceral pain)
Timepoint
Two, four, six, twelve and twenty-four hours after surgery
Method of measurement
Visual analog scale
Intervention groups
1
Description
Intervention group: TAP (transverse abdominis plane) Block Group, in this group local anesthetic (20 cc Bupivacaine .25 percent) will be injected in the transverse abdominis plane which is the site of the passage of the C fibers of the pain via ultrasound technique
Category
Treatment - Other
2
Description
Intervention group: Local anesthesia infiltration , in this group of the intervention local anesthetic (20 cc Bupivacaine .25 percent) will be injected in the surrounding site of the surgery wound
Category
Treatment - Other
3
Description
Control group: No intervention method, such as the classic and routine method, in this group no intervention in the operating room setting for the control of the post operative pain will be done.
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Kashan University of Medical Sciences
Full name of responsible person
Mehdi Rajabi
Position
Pain anesthesiologist pain fellow
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Kashan Imam Hossein Square
City
Kashan
Province
Isfehan
Postal code
3791194955
Phone
+98 31 5545 3216
Email
rajabim98@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mehdi Rajabi
Position
Anesthesiologist and pain fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Kashan Imam Hossein Square
City
kashan
Province
Isfehan
Postal code
3791194955
Phone
+98 31 5545 3216
Email
rajabim98@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Majid Vahbizad
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Kashan county, Imam Hossein square
City
kashan
Province
Isfehan
Postal code
3791194955
Phone
+98 31 5554 3020
Email
vahabizad@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
The data obtained from the comparison of the two methods of TAP block and infiltration in patients in comparison with the control group will be presented in the form of published text.
When the data will become available and for how long
After the implementation of the plan
To whom data/document is available
Vice Chancellor for University Research and researchers and project consultants.
Under which criteria data/document could be used
The data is usable and valuable in any outcome.
From where data/document is obtainable
Vice Chancellor for Research and Technology of Kashan University of Medical Sciences.
What processes are involved for a request to access data/document
Necessary coordination should be provided in the Research Council of Kashan University of Medical Sciences according to the approved laws.