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IRCT20131226015941N7 IRCT 2019-05-12 Kerman University of Medical Sciences Intravenous fentanyl vs. erector spinae block in chest trauma pain Acheiving analgesia in chest trauma related pain in the emergency department: intravenous fentanyl or ultrasound guided erector spinae block 2019-05-22 anticipated 60 Complete https://irct.ir/trial/39131 interventional Randomization: Randomized, Blinding: Not 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. 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. 3 Unspecified injury of thorax (chest trauma). Intervention 1: 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. Intervention 2: 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). Yes - There is a plan to make this available What will be shared: All de-identified 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 16 years of age presenting to the emergency department with chest trauma initial pain score over 5 (from 10) 16 years no limit Both 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) S29.9XXA unspecified injury of thorax Treatment - Drugs Treatment - Drugs 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. 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). Pain score. Timepoint: 20 minutes and 1 hour after injection or block. Method of measurement: asking the patient by numeric rating scale. 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. Adverse reactions of the intervention(s). Timepoint: at the discharge time. Method of measurement: assessment 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)