Protocol summary

Study aim
Determining and comparing the pain during chest tube insertion in trauma patients in two methods local anesthesia and intercostal nerve block.
Design
After obtaining consent, patients will be randomly assigned to intervention or control groups. Data will be analyzed using SPSS, with statistical significance set at p < 0.05.
Settings and conduct
Absence of similar studies, low complications, and high efficacy in the trauma emergency room of Shahid Beheshti Hospital, Kashan Patients are divided into intervention and control groups, in the intervention group, intercostal block and local anesthesia are performed, and in the control group, only local anesthesia is performed.
Participants/Inclusion and exclusion criteria
Blunt or penetrating trauma to the chest that requires the insertion of a chest tube-Absence of severe respiratory distress- Vital signs in the form of pulse rate less than 100, systolic blood pressure 4. greater than 90, respiratory rate less than 30, oxygen saturation percentage greater than 95-The level of consciousness with the GCS index should be equal to and greater than 14. No need for emergency surgery-No addiction to opioid drugs exit :It is not possible to follow the patient for up to one hour due to surgery, decreased level of consciousness, or death
Intervention groups
In the intervention group, to perform an intercostal block, lidocaine 2% is injected in the lower edge of the 5th to 7th ribs in the posterior axillary line (3 cc for each rib). Then local anesthesia is also injected with 2% lidocaine using a 10 ml syringe and a 22G needle in the 5th or 6th intercostal space in the middle axillary line in different directions.
Main outcome variables
Age, sex, type of trauma, heart rate, blood pressure, respiratory rate, o2 saturation percentage, type of analgesia, pain score, narcotics intake, reasons for not performing intercostal nerve block, nationality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240530061951N1
Registration date: 2024-07-04, 1403/04/14
Registration timing: prospective

Last update: 2024-07-04, 1403/04/14
Update count: 0
Registration date
2024-07-04, 1403/04/14
Registrant information
Name
sina sadati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0249
Email address
sinasadati78@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-21, 1403/05/31
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the analgesic effect of intercostal block in reducing pain during chest tube insertion in trauma patients referred to Shahid Beheshti Hospital in Kashan
Public title
analgesic effect of intercostal block in reducing pain during chest tube insertion in trauma patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Blunt or penetrating trauma to the chest that requires the insertion of a chest tube Absence of severe respiratory distress Vital signs in the form of pulse rate less than 100, systolic blood pressure greater than 90, respiratory rate less than 30, oxygen saturation percentage greater than 95 The level of consciousness with the GCS index should be equal to and greater than 14 No need for emergency surgery No addiction to opioid drugs
Exclusion criteria:
It is not possible to follow the patient up to one hour due to surgery, decreased level of consciousness or death
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done through blocks of 6
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the patients participating in the study have been kept blind
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of kashan university of medical sciences
Street address
pezeshk blvd, qotb ravandi blvd, kashan
City
kashan
Province
Isfehan
Postal code
8715973474
Approval date
2024-03-15, 1402/12/25
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1402.305

Health conditions studied

1

Description of health condition studied
Hemothorax- pneumothorax
ICD-10 code
S27.0
ICD-10 code description
Traumatic pneumothorax

Primary outcomes

1

Description
Pain intensity using the VAS chart (score from 0 to 10 as a fraction)
Timepoint
During thoracostomy tube insertion and one hour after
Method of measurement
Visual Analogue Scale chart

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Lidocaine 2% on the lower edge of the 5th to 7th ribs in the posterior axillary line - 3 cc for each rib
Category
Treatment - Surgery

2

Description
Control group: Local anesthesia is injected with 2% lidocaine using a 10 ml syringe and a 22G needle in the 5th or 6th intercostal space in the middle axillary line in different directions.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital in Kashan
Full name of responsible person
Dr. Sajjad Zarrati
Street address
Pezeshk Blvd., Qotb Ravandi Blvd., Kashan
City
kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 9999
Email
info@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Sajjad Zarrati
Street address
Pezeshk Blvd., Qotb Ravandi Blvd., Kashan
City
kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 9999
Email
info@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
2
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Sajjad Zarrati
Position
Resident Of General Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Pezeshk Blvd., Qotb Ravandi Blvd., Kashan
City
kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5554 0139
Email
sajad.zarati@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Noushin Sadat Mousavi
Position
Assistant Professor of General Surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Pezeshk Blvd., Qotb Ravandi Blvd., Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5510 9999
Email
moosavi_n@kaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Sina Sadati
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Iman Street, Mofatteh Blvd., Kashan
City
kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5554 0249
Email
sinasadati78@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only a part of the data, such as the information related to the main result or the like, can be shared.
When the data will become available and for how long
Access started from 2025
To whom data/document is available
Researchers of scientific and academic centers
Under which criteria data/document could be used
No further information is required
From where data/document is obtainable
Scientific respondent of the project
What processes are involved for a request to access data/document
Send an email to the project's corresponding author
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