Protocol summary
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Study aim
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Comparison of the effect of Serratus anterior plain block technique with intercostal nerve block technique in reducing pain following multiple rib fractures in emergency department
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Design
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Two arm parallel groups randomized clinical trial with single blinded post interventional care and outcome assessment
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Settings and conduct
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In the test group, patients will undergo regional anesthesia using serratus anterior plane block technique. In the control group, the intercostal nerve block technique is performed. The study will be single_blinded, and the registrants before and after the intervention are unaware of the patient grouping. Improvement of certain symptoms provided in a modified qor-40 checklist and visual analogue score will be recorded
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Participants/Inclusion and exclusion criteria
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Study subjects include patients who refer to Imam Reza and Ayatollah Taleghani hospitals in Kermanshah, with blunt thoracic trauma during 2019,
three or more traumatic rib fractures,
aged 18 years or more,
Initial consent
Visual analogue score of 4 and more
Initial systolic blood pressure of 90 mmHg and more
and patients addmited and monitored at least twelve hours after interventions
Patients with opium addiction, pathologic and/or non-traumatic rib fractures , bilateral rib fractures, history of local anesthetic sensitivity, pregnant and/or lactating and those suffering from mental or psychological problems will not be included.
Patients who progress toward tension pneumothorax and whom need intubation and mechanical ventilation will be excluded
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Intervention groups
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Patients referred to Imam Reza and Ayatollah Taleghani hospitals in Kermanshah, during 2019 with traumatic three and/or more rib fractures who will undergo regional anesthesia by Serratus anterior plane block technique
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Main outcome variables
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Visual analogue scale & Modified qor-40 SCORE changes
General information
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Reason for update
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Information for termination of sampling have been entered -
The realized date of commencement and termination of sampling is also different from the expected dates which are entered in the relevant columns.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190314043050N1
Registration date:
2019-05-27, 1398/03/06
Registration timing:
prospective
Last update:
2019-12-22, 1398/10/01
Update count:
1
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Registration date
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2019-05-27, 1398/03/06
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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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2019-04-25, 1398/02/05
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Expected recruitment end date
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2019-05-26, 1398/03/05
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Actual recruitment start date
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2019-05-28, 1398/03/07
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Actual recruitment end date
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2019-08-23, 1398/06/01
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Trial completion date
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2019-09-23, 1398/07/01
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Scientific title
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Comparison of the effect of Serratus anterior plain block technique with intercostal nerve block technique in reducing pain following multiple rib fractures in emergency department
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Public title
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Serratus anterior plane block technique in multiple traumatic rib fractures
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients referred to Imam Reza and Ayatollah Taleghani hospital in Kermanshah, with a complaint of blunt thoracic trauma during 2019
Visual analogue scale of four and more
Initial systolic blood pressure of 90 mmHg and more
Three-rib fractures and more
The patient should be monitored at least twelve hours after interventions
Exclusion criteria:
Opium addicted patients
Pathologic and/or Nontraumatic rib fractures
Bilateral rib fractures
history of allergy to local anesthetics
Pregnancy and/or breastfeeding
People with mental and psychological problems who are not able to answer questions
Tension pneumothorax occurs
Need to intubation and mechanical ventilation
Patient dissatisfaction
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Age
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From 18 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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Sample size
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Target sample size:
40
Actual sample size reached:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients are randomly divided into control and test groups by the complete randomization method
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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after completing interventions, patients' evaluation checklist will be decoded. Assessment and registration is carried out by a specific person for each patient. These evaluators are blind to the type of the procedure performed in the recovery room. In fact, Patient information is recorded before and after the process by the assistant who is unaware of the him/her study grouping.
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Placebo
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Not used
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Assignment
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Other
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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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2019-04-24, 1398/02/04
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Ethics committee reference number
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IR.KUMS.REC.1398.065
Health conditions studied
1
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Description of health condition studied
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Multiple traumatic rib fractures
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ICD-10 code
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S22
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ICD-10 code description
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Fracture of rib(s), sternum and thoracic spine
Primary outcomes
1
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Description
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score changes in visual analogue scale system
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Timepoint
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Immediately after the intervention, the first 30 minutes, one, six, and 12 hours after
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Method of measurement
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Visual analogue scale and modified Qor-40 score checklist
Secondary outcomes
1
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Description
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Dosage of Fentanyl used
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Timepoint
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thirty minutes to twelve hours after intervention
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Method of measurement
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Microgram per Kg
Intervention groups
1
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Description
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Intervention group: serratus anterior plane block technique under ultrasound guidance. This method is similar to the pectoralis nerve and trans-abdominal plate blocks and, due to the special anatomy of the Sarratus muscle, it traverses a wide area of the chest wall. Patients in the intervention group will be in a supine position with the hands placed above the head. After providing sterile conditions, local anesthetic technique begins. An ultrasound linear probe of 3 to 16 MHz is placed in the middle axillary line at the fifth rib. A Touhy's 18G needle is placed between the anterior serratus and the external intercostal muscles. After negative aspiration and confirmation of needle location by initial hydro-dissection with 2 to 3 ml of solution, 20 ml of Ropivacaine hydrochloride will be injected 5 mg / ml in the cephalad_caudal direction on the plate.
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Category
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Treatment - Other
2
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Description
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Control group: intercostal nerve block. This procedure is done between the posterior and middle axillary lines. A 10-ml syringe with a needle of 3.375 and 25 guage is used. The skin of the affected area will be prepared by the usual aseptic method. To perform this technique, the second finger of the non-dominant hand draws the lower edge of the rib upwards. The needle at an angle of 80 degrees to the chest wall, enters the skin to slowly hit the lower edge of the rib. At this time, the finger is removed and the needle is pulled in the intercostal space. We dip the needle 3 millimeter and aspirate. Then, 2 to 4 ml of ropivacaine hydrochloride will be given at a dose of 5 mg / ml to a maximum dose of 2.5 mg per kg body weight. The procedure is repeated in two gears up and down the premises.
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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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Kermanshah 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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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The whole potential data can be shared after identifying individuals and their information
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When the data will become available and for how long
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Since 1399
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To whom data/document is available
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Researchers working in academic institutions
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Under which criteria data/document could be used
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From where data/document is obtainable
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Ah_meysami@kums.ac.ir
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What processes are involved for a request to access data/document
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After contacting the designer email
Ah_meysami@kums.ac.ir
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Comments
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