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IRCT20131226015941N9 IRCT 2021-01-16 Kerman University of Medical Sciences Erector spinae block vs. intercostal nerve block in thoracic trauma Ultrasound guided erector spinae block vs. ultrasound guided intercostal nerve block for thoracic trauma pain management in the emergency department 2021-02-03 anticipated 76 Complete https://irct.ir/trial/53686 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A 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) 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All data related to all patients could be shared after deidentification if requested. When: The data could be shared immediately after publication. No time limit is considered. To whom: Data will be available to all relevant academic researchers following reception of their proposal and explanation for the reason(s) of their request. Conditions: The applicants should send their proposal to be evaluated. No specific pre-defined limit is considered. Where to obtain: Please send an email to mirafzal@kmu.ac.ir. How to obtain: Data will be available in 3 weeks following sending the email with proposal attached. 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
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 a.mirafzal@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) َAll adult patients with thoracic trauma initial pain score over 5 using numeric pain scale (0-10) 18 years no limit Both 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 S29.9XXA Unspecified injury of thorax Treatment - Other Treatment - Other 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. 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. Pain score (using numeric rating scale) 20 minutes following the procedures. Timepoint: Twenty minutes following the procedures. Method of measurement: Asking the patient. Pain score minutes following the procedures. Timepoint: Sixty minutes following the procedures. Method of measurement: Asking the patient. Total fentanyl dose administered. Timepoint: Six hours following admission. Method of measurement: Physician order and Nurse report. Kerman University of Medical Sciences Approved 2021-01-02 Ethics committee of Kerman University of Medical Sciences Somaye crossroad, Jahad Blv., Ebne-Sina St., next to Besat Clinic Kerman Kerman Iran (Islamic Republic of)