To compare the analgesic effect of erector spinae block with intravenous fentanyl in chest trauma related pain in the emergency department
Design
Randomized, parallel group trial without blinding. Randomization will be done by simple randomization using random numbers table.
Settings and conduct
This study will be conducted in Bahonar Academic Hospital located in Kerman, Iran. Enrolled patients will undergo ultrasound guided erector spinae block (performed by a trained senior resident of emergency medicine under the supervision of an attending physician of emergency medicine with 2 years of experience) or will receive intravenous fentanyl (1 microgram/kg). Assessment of pain scores (using a numeric rating scale from 0 to 10) will be performed before and 20 minutes after analgesia by a registered nurse on duty . After 20 minutes, patients in both groups will receive 1 microgram/kg of intravenous fentanyl if pain scores does not relieve (at least 2 points); this will be repeated each 20 minutes until the required pain reduction (at least 2 points) will be achieved. pain score at 1 hour and the total consumed fentanyl will be recorded.
Participants/Inclusion and exclusion criteria
All patients over 16 years of age who present to the emergency deprtament with chest trauma and pain scores over 5 (of 10) will be included. Those with distracting injuries, impaired consciousness, lidocaine or fentanyl hypersensitivity, coagulopathy, sensory deficit and those who are not willing to participate or have already received pain medications will be excluded.
Intervention groups
Group 1 will undergo ultrasound guided erector spinae fascial plain block, while group 2 receives intravenous fentanyl (1 microgram/kg).
Main outcome variables
Pain score at 20 minutes after the block or fentanyl injection; pain scores at 1 hour, total fentanyl dose and adverse outcomes in each group are secondary outcomes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131226015941N7
Registration date:2019-05-12, 1398/02/22
Registration timing:prospective
Last update:2019-05-12, 1398/02/22
Update count:0
Registration date
2019-05-12, 1398/02/22
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
2019-05-22, 1398/03/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Acheiving analgesia in chest trauma related pain in the emergency department: intravenous fentanyl or ultrasound guided erector spinae block
Public title
Intravenous fentanyl vs. erector spinae block in chest trauma pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 16 years of age presenting to the emergency department with chest trauma
initial pain score over 5 (from 10)
Exclusion criteria:
presence of distracting injuries
impaired consciousness
hypersensitivity to lidocaine or fentanyl
presence of coagulopathy
presence of any sensory impairment like peripheral neuropathy
receiving pain killers before enrollment
those who are not willing to participate or to continue their cooperation
need for surgical intervention through the chest wall (including tube thoracostomy)
Age
From 16 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized by simple randomization method using random numbers table. Each patient will be the unit of randomization. Even numbers will be assigned as group 1 (erector spinae block) and odd number to group 2 (intravenous fentanyl). Allocation concealment is not possible in this study.
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 committe 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
2019-04-23, 1398/02/03
Ethics committee reference number
IR.KMU.REC.1398.049
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
Timepoint
20 minutes and 1 hour after injection or block
Method of measurement
asking the patient by numeric rating scale
Secondary outcomes
1
Description
total dose of intravenous fentanyl administered to achieve adequate analgesia
Timepoint
The first 6 hours of admission in the emergency department
Method of measurement
recording by the investigator
2
Description
adverse reactions of the intervention(s)
Timepoint
at the discharge time
Method of measurement
assessment by the investigator
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) 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, 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 - Drugs
2
Description
Control group: Intravenous fentanyl (Caspiantamin, Iran) will be administered by slow injection (during 2 minutes) under cardiac monitoring and pulse oximetry in the resuscitation room. Each dose of fentanyl will be 1 microgram/kg of estimated lean body weight (usually 65-75 microgram in an adult). The dose may be repeated if the patient does not report pain reduction by at least 2 points after 20 minutes intervals in the first hour and hourly thereafter (After the first dose the injection may be performed in both intervention or control groups).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahonar Academic Hospital
Full name of responsible person
Amirhossein Mirafzal
Street address
Bagh-e-Melli
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?