To compare the analgesic effects of ultrasound guided femoral nerve block with ultrasound guided fascia iliaca block in femoral fractures
Design
Randomized, parallel group trial with blinded outcome assessment. Randomization will be done by simple randomization using random numbers table.
Settings and conduct
This study will be conducted in Bahonar Academic Hospital, a level 2 urban trauma center located in Kerman, Iran. Enrolled patients will undergo ultrasound guided fascia iliaca or femoral nerve block, performed by a specifically trained senior resident of emergency medicine, which will be directly supervised by an attending physician of emergency medicine with 2 years of academic experience in both of the block methods. Assessment of pain scores (using a numeric rating scale) will be performed before and 20 minutes and 1 hour after the procedure and in the time of disposition from the emergency department by a registered nurse on duty who is blinded to the method of block.
Participants/Inclusion and exclusion criteria
All patients over 18 years of age with femoral fractures will be included. Those with distracting injuries, impaired consciousness, lidocaine hypersensitivity, coagulopathy, sensory deficit and those who have already received pain medications will be excluded.
Intervention groups
The two groups will undergo two kinds of ultrasound guided blocks: for group 1 fasica iliaca block and for group 2 femoral nerve block will be performed.
Main outcome variables
Pain scores 20 minutes and 1 hour after the procedure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131226015941N8
Registration date:2019-05-16, 1398/02/26
Registration timing:prospective
Last update:2019-05-16, 1398/02/26
Update count:0
Registration date
2019-05-16, 1398/02/26
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
Ultrasound guided femoral nerve vs. fascia iliaca block: A randomized trial of analgesia in femoral injury
Public title
Ultrasound guided femoral nerve vs. facia iliaca block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years of age
Patients with proximal femoral fracture
Patients with femoral shaft fracture
Exclusion criteria:
Presence of distracting injury
Impaired consciousness
Hypersensitivity to lidocaine
Coagulopathy
Sensory deficit in the limbs for any reason
Not willing to participate in the study
Receiving pain killers before enrollment
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
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. The sequence of numbers will be read from top to bottom, starting from the left column. Even numbers will be assigned as group 1 (fascia iliaca block) and odd numbers as group 2 (femoral nerve block). Allocation concealment will be done using sealed opaque envelopes. The group assigned to each number will be written on a small paper and put in the envelope. The sequential numbers of the patients will be written on the envelopes, which are kept safe by the head-nurse of the emergency department.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants of the study will be blinded to the study group since the syringes and agents used for both blocks are similar (lidocaine) and the techniques of block are almost the same from the outside view (the main difference between the two methods is recognizable by the ultrasound view which will not be available for the patient).
The person who will be evaluating the pain scores of the patient before and after the blocks will be blinded to the procedure. He/She will be a registered nurse on duty.
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.1398.050
Health conditions studied
1
Description of health condition studied
Femoral fracture
ICD-10 code
S72
ICD-10 code description
Unspecified fracture of femur
Primary outcomes
1
Description
Pain score by numeric rating scale at 20 minutes after the procedure
Timepoint
Twenty minutes after the procedure
Method of measurement
Asking the patient
2
Description
Pain score by numeric rating scale at 1 hour after the procedure
Timepoint
One hour after the procedure
Method of measurement
Asking the patient
Secondary outcomes
1
Description
Total administered dose of intravenous fentanyl (if administered)
Timepoint
After 1 hour from the procedure to the time of disposition
Method of measurement
Recording by the investigator
2
Description
Complications of the procedure
Timepoint
From the beginning of the procedure to the discharge of the patients
Method of measurement
Evaluation by the investigator
Intervention groups
1
Description
Intervention group: Fascia iliaca 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 2 years experience of the procedure. Firstly, fascia iliaca will be recognized in the ultrasound view of the lowest part of the abdomen 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: Femoral nerve block is assigned as the control procedure since there have been more research on it and its superiority relative to systemic analgesia has been confirmed by the literature. Femoral 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 2 years experience of the procedure. Firstly, femoral nerve, artery and vein will be recognized in the ultrasound view of the inguinal region and using a 20 gauge needle, 20 ml of 1% lidocaine (Caspiantamin, Iran) will be injected in the sheath covering the nerve (puncture of the nerve itself should be avoided by the performer); tissue expansion is checked by ultrasound in the time of injection.
Category
Treatment - Drugs
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?