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IRCT20211019052817N1 IRCT 2021-11-13 Kermanshah University of Medical Sciences The effect of lumbar arch support in the prevention of low back pain during spinal anesthesia Study of the effect of lumbar arch support in the prevention of low back pain during spinal anesthesia: A clinical trial 2021-11-10 anticipated 154 Complete https://irct.ir/trial/59470 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Using a table of random numbers. Patients based on random numbers generated by the program (Excel version 2016 and RANDBETWEEN function) that values less than 5.0 (0.0009-0.000) will be assigned to the intervention group and more than 5.0 (0.500-999) will be assigned to the control group, Blinding description: The project partner, who does not know how the volunteers are assigned in the groups, will evaluate the incidence and severity of low back pain in the project. N/A Low back pain. Intervention 1: In the intervention group, patients will be asked to place an air mattress under the lumbar vertebrae according to the anatomical position before surgery and after performing spinal anesthesia in the supine position until the anesthetic effect wears off. Intervention 2: No intervention will be performed in the control group. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Dr. Omid Bahiraei
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6306 omid39bahiraee@gmail.com Kermanshah University of Medical Sciences scientific Dr. Javad Amini Saman
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6306 aminisaman399@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Age over 18 years old Patient satisfaction No history of mental illness 18 years no limit Both Patients with a history of taking painkillers (opioids or non-opioids) or any drugs in one recent week. Having symptoms of high intracranial pressure Abnormal spinal anatomy such as scoliosis Coagulation problems Patients with low back pain during previous spinal anesthesia M54.5 Low back pain Treatment - Other Other In the intervention group, patients will be asked to place an air mattress under the lumbar vertebrae according to the anatomical position before surgery and after performing spinal anesthesia in the supine position until the anesthetic effect wears off. No intervention will be performed in the control group Pain intensity. Timepoint: 6 hours, 24 hours and 7 days after surgery. Method of measurement: The visual analog scale. Kermanshah University of Medical Sciences Approved 2021-11-07 Ethics committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)