Comparison of ultrasound guided erector spinae block with ultrasound guided intercostal nerve block for pain management of thoracic trauma in the emergency department
Design
Randomized, non-blinded, two arm parallel on 76 patients (two groups with at least 38 in each group). Simple randomization was performed using random numbers table.
Settings and conduct
This study will be performed in Bahonar Academic Hospital in Kerman, Iran. A post graduate year 3 resident of emergency medicine (EM) will perform the blocks under direct supervision of an attending physician of EM.Group 1 will be assigned to ultrasound guided erector spinae block and group 2 to ultrasound guided intercostal nerve block. The numeric pain scale score will be used for pain quantification, with 0 as the least and 10 as the worst pain possible. The pain score will be asked at 20 and 60 minutes following the procedures. If the patient does not report the least acceptable pain reduction after 20 minutes (at least 2 points lower than the initial score AND the score under 7) a dose of fentanyl (1 micrograms/Kg) will be administered intravenously. Main Outcomes are pain scores after 20 and 60 minutes and the total fentanyl dose in the emergency department. This trial could not be blinded.
Participants/Inclusion and exclusion criteria
Adult patients with thoracic trauma and initial pain score over 5 (out of 10) are included. Patients with distracting injuries, contraindications to Lidocaine, Need for surgical interventions in thorax, altered mental status, impaired pain sensation and those who refuse to participate will be excluded.
Intervention groups
Group 1: Erector spinae fascial plain block under ultrasound guidance
Group 2: Intercostal nerve block under ultrasound guidance
Main outcome variables
Main outcomes are pain scores after 20 and 60 minutes and the total fentanyl dose in the emergency department.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131226015941N9
Registration date:2021-01-16, 1399/10/27
Registration timing:prospective
Last update:2021-01-16, 1399/10/27
Update count:0
Registration date
2021-01-16, 1399/10/27
Registrant information
Name
Amirhossein Mirafzal
Name of organization / entity
Kerman University of Medical sceinces
Country
Iran (Islamic Republic of)
Phone
+98 34 1247 4638
Email address
mirafzal@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-03, 1399/11/15
Expected recruitment end date
2021-06-05, 1400/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Ultrasound guided erector spinae block vs. ultrasound guided intercostal nerve block for thoracic trauma pain management in the emergency department
Public title
Erector spinae block vs. intercostal nerve block in thoracic trauma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
َAll adult patients with thoracic trauma
initial pain score over 5 using numeric pain scale (0-10)
Exclusion criteria:
Distracting injuries
Altered mental status
Any contraindications to Lidocaine
Need for tube thoracostomy or thoracic surgery
Impaired pain perception (Neuropathies, etc.)
Large painful area (which can not be managed using intercostal nerve block)
Patient refusal to participate
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized using simple randomization by random numbers table. Each individual will be the unit of randomization. The random sequence will be built by blindly pointing one number in the list and enter the number in the first 2 digits is between 01 and (at least) 76 (minimum sample size). This place will be assigned to the erector spinae group if the right sided digit is even and to the intercostal group if it is odd. The process will be continued until at least 38 locations are allocated for each group. Allocation concealment will not be done since this trial could not be performed blindly.
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 Kerman University of Medical Sciences
Street address
Somaye crossroad, Jahad Blv., Ebne-Sina St., next to Besat Clinic
City
Kerman
Province
Kerman
Postal code
7610813159
Approval date
2021-01-02, 1399/10/13
Ethics committee reference number
IR.KMU.AH.REC.1399.137
Health conditions studied
1
Description of health condition studied
Unspecified injury of thorax (chest trauma)
ICD-10 code
S29.9XXA
ICD-10 code description
Unspecified injury of thorax
Primary outcomes
1
Description
Pain score (using numeric rating scale) 20 minutes following the procedures
Timepoint
Twenty minutes following the procedures
Method of measurement
Asking the patient
2
Description
Pain score minutes following the procedures
Timepoint
Sixty minutes following the procedures
Method of measurement
Asking the patient
3
Description
Total fentanyl dose administered
Timepoint
Six hours following admission
Method of measurement
Physician order and Nurse report
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Erector spinae fascial plain block will be performed under the real time vision by the ultrasound device (Mindray, 2012, China) The block will be performed by a senior resident of emergency medicine (EM) trained by a pain medicine fellow. The procedure will be supervised by an attending physician of EM with certification of ultrasound guided nerve blocks and 3 years of experience in the procedure. Firstly, erector spinae fascial plain will be recognized in the ultrasound view of the mid-thorax region in the affected side at the level of the transverse process of T5 (by the high frequency probe) and using a 20 gauge needle, 20 ml of 1% Lidocaine (Caspiantamin, Iran) will be injected under the fascia; tissue expansion is checked by ultrasound in the time of injection.
Category
Treatment - Other
2
Description
Control group: Intercostal nerve block will be performed under the real time vision by the ultrasound device (Mindray, 2012, China) and after proper sterile preparations. The block will be performed by a senior resident of Emergency Medicine trained by a pain medicine fellow. The procedure will be supervised by an attending physician of emergency medicine with certification of ultrasound guided nerve blocks and one year of experience in the procedure. Firstly, The rib with the most intense pain is recognized in the ultrasound view of the posterior axillary line in the affected side by the high frequency probe and using a 20 gauge needle, 5 ml of 1% lidocaine (Caspiantamin, Iran) will be injected under the inner suface of the rib; this procedure is repeated for 2 ribs upper and 2 ribs lower than the first site with 3-4 ml of 1% Lidocaine.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahonar Academic Hospital
Full name of responsible person
Amirhossein Mirafzal
Street address
Gharani St.
City
Kerman
Province
Kerman
Postal code
7618747181
Phone
+98 34 3223 5011
Email
mirafzal@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Somaye crossrd., Jahad blv., Kerman
City
Kerman
Province
Kerman
Postal code
7116913555
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?