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IRCT20131226015941N8 IRCT 2019-05-16 Kerman University of Medical Sciences Ultrasound guided femoral nerve vs. facia iliaca block Ultrasound guided femoral nerve vs. fascia iliaca block: A randomized trial of analgesia in femoral injury 2019-05-22 anticipated 60 Complete https://irct.ir/trial/39032 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Femoral fracture. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All deidentidied data set will be available for primary and secondary outcomes. When: Starting 1 year after publication To whom: The data will be available only for people in academic positions. Conditions: No limitation considered for this part. Where to obtain: please email your request to mirafzal@kmu.ac.ir The responsible person is Amirhossein Mirafzal How to obtain: The data set will be provided in one month Comments:
public Amirhossein Mirafzal
Bahonar Hospital, Gharani St., Bagh-e-Melli crossrd., Kerman
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 mirafzal@kmu.ac.ir Kerman University of Medical Sciences scientific Amirhossein Mirafzal
Bahonar Hospital, Gharani St., Bagh-e-Melli crossrd., Kerman, Iran
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 mirafzal@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years of age Patients with proximal femoral fracture Patients with femoral shaft fracture 18 years no limit Both 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 S72 Unspecified fracture of femur Treatment - Drugs Treatment - Drugs 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. 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. Pain score by numeric rating scale at 20 minutes after the procedure. Timepoint: Twenty minutes after the procedure. Method of measurement: Asking the patient. Pain score by numeric rating scale at 1 hour after the procedure. Timepoint: One hour after the procedure. Method of measurement: Asking the patient. 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. Complications of the procedure. Timepoint: From the beginning of the procedure to the discharge of the patients. Method of measurement: Evaluation by the investigator. Kerman University of Medical Sciences Approved 2019-04-23 Ethics committe of Kerman University of Medical Sciences Somaye crossroad, Jahad Blv., Ebne-Sina St., next to Besat Clinic Kerman Kerman Iran (Islamic Republic of)