Protocol summary
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Study aim
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Pain due to multiple (3-4) rib fractures of trauma patients compared between the thoracic epidural block and intercostal block.
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Design
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Clinical trial without a control group, with parallel groups, double-blind, performed on 86 patients.
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Settings and conduct
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The study is a randomized double-blind clinical trial in which patients with 3-4 rib fractures who are referred to Valiasr hospital in Arak who do not have pneumothorax and hemothorax are randomly divided into two groups.
The thoracic epidural or intercostal block is performed by an anesthesiologist and then the intern in charge of the project, who is unaware of the grouping, will record the patients' information including pain score, hemodynamics, etc. in the questionnaire. Also, the statistician of the project consultant, who is not aware of the groups and only analyzes the two groups A and B.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with 3-4 rib fractures, age between 15 to 50 years, no underlying heart and lung disease, no hemothorax or pneumothorax, no pulmonary contusion, no sensitivity to marcaine and lidocaine, no drug allergy
Exclusion criteria: patient's unwillingness to participate in the plan, contraindication for epidural or intercostal block, History of drug addiction
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Intervention groups
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Group A: patients with the thoracic epidural block.
Group B: patients with the intercostal block.
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Main outcome variables
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Pain by score, mean of drug use, mean heart rate,
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20161017030336N8
Registration date:
2021-11-23, 1400/09/02
Registration timing:
retrospective
Last update:
2022-08-03, 1401/05/12
Update count:
1
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Registration date
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2021-11-23, 1400/09/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-05-04, 1400/02/14
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Expected recruitment end date
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2021-09-05, 1400/06/14
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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comparison between thoracic epidural and intercostal block in pain management of patients with 3-4 traumatic rib fracture
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Public title
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comparison between thoracic epidural and intercostal block in pain management of patients with 3-4 traumatic rib fracture
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with 3-4 rib fractures
Age between 15 to 50 years
Lack of underlying heart and lung disease
Absence of hemothorax and pneumothorax
Absence of pulmonary contusion
Lack of sensitivity to marcaine and lidocaine
Lack of sensitivity to drugs
Exclusion criteria:
The patient's unwillingness to participate in the plan
History of drug addiction
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Age
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From 15 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
86
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Thoracic trapezius or intercostal block is performed by the anesthesiologist in charge of the project and then the intern in charge of the project who is unaware of the grouping, patient information including pain score, hemodynamics, etc. will be recorded in the questionnaire. Also, the project consultant statistician who is in charge of data analysis is not aware of the groups and only analyzes the two groups A and B.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-05-03, 1400/02/13
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Ethics committee reference number
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IR.ARAKMU.REC.1400.002
Health conditions studied
1
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Description of health condition studied
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Fracture of thoracic vertebra
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ICD-10 code
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S22.0
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ICD-10 code description
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Fracture of thoracic vertebra
2
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Description of health condition studied
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Multiple fractures of ribs
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ICD-10 code
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S22.4
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ICD-10 code description
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Multiple fractures of ribs
Primary outcomes
1
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Description
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Pain
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Timepoint
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In 15 minutes, one hour, 2 hours, 4 hours, 12 hours, 24 hours
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Method of measurement
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Visual Analogue Scale. In this scale, the number zero is considered painless and the number 10 is considered the maximum amount of pain.
Intervention groups
1
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Description
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Intervention group 1: Patients with thoracic epidural block are placed in a sitting position after taking a vein and giving 3 cc per kg of normal saline, and after washing the area using an epidural needle 20 in the thoracic space, depending on the fracture of the ribs, we will block the patient.The desired dose for the patient using marcaine is 0.25 to 0.3 cc per kg.
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Category
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Treatment - Other
2
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Description
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Intervention group 2: Patients in the intercostal block group, after taking a vein and giving 3 cc / kg of normal saline while sitting or lying on their side, then the target area is washed and the intercostal block is prepared. Using a G22 needle and according to the fracture site, nerve block is performed through the intercostal space in the posterior region. The desired dose for inter-gear block is 0.2 cc / kg of marcaine 0.25.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Arak University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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All data is potentially shareable after unidentified individuals
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When the data will become available and for how long
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The access period starts 6 months after the results are published
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To whom data/document is available
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Available only to researchers working in academic and scientific institutions.
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Under which criteria data/document could be used
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There are no conditions for access to information.
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From where data/document is obtainable
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Vice Chancellor for Research, Arak University of Medical Sciences.+98 86 3417 3505
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What processes are involved for a request to access data/document
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The applicant can access the documents immediately after contacting the Vice Chancellor for Research of Arak University of Medical Sciences.
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Comments
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