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IRCT20180325039148N5 IRCT 2021-10-19 Zanjan University of Medical Sciences The effect of magnesium sulfate on lower limb anesthesia The Effect of Adding Magnesium Sulfate to Ropivacaine in Femoral Nerve Block before Spinal Anesthesia on Pain Management in Femoral Fracture Surgeries: A Randomized Clinical Trial 2021-10-23 anticipated 104 Complete https://irct.ir/trial/59328 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples will be assigned to the two groups by blocking the classification method based on age and sex. The blocks will be selected randomly with size 4. Proc PLAN SAS will be used to prepare the blocks and is given to the researcher who is responsible for collecting samples, and based on the code assigned to each patient (A, B, C, D), individuals are divided into two groups without a researcher's interference, Blinding description: Patients know that they are participating in a study aimed at investigating the effect of femoral nerve block with Ropivacaine + normal saline and femoral nerve block with Ropivacaine + magnesium sulfate on pain management in femoral fracture surgery, but are unaware that Ropivacaine + Normal saline or Ropivacaine + Magnesium sulfate is used in the block of the femoral nerve for them. Medications are coded, and the anesthetist who injects the medication does not know what type of medication the patients are receiving. The person measuring the response or pain intensity will be unaware of the nature of the groups. 3 femoral fracture. Intervention 1: Intervention group: Ultrasound-guided femoral nerve block (eZono AG/D-07743 Jena, Germany) will be performed before spinal anesthesia as 15 ml of ropivacaine 0.2% (made by MOLTEN) + 0.5 ml of magnesium sulfate 50% (made by Shahid Ghazi Tabriz). Intervention 2: Control group: Ultrasound-guided femoral nerve block (eZono AG/D-07743 Jena, Germany) will be performed before spinal anesthesia as 15 ml of ropivacaine 0.2% (made by MOLTEN) + 0.5 ml of normal saline (made by Shahid Ghazi Tabriz). No - There is not a plan to make this available Justification or reason for not sharing IPD is -
public Saeed Jalili
Ayatollah Mousavi Hospital, Gavazang Blvd, Zanjan
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0001 jalilis45@zums.ac.ir Zanjan University of Medical Sciences scientific Saeed Jalili
Ayatollah Mousavi Hospital, Gavazang Blvd, Zanjan
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0001 jalilis45@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) 18-75 years old American Society of Anesthesiologists (ASA) Class I & II Patients candidates for femoral fracture surgery 18 years 75 years Both Coagulation disorder History of drug allergy History of peripheral neuropathy Existence of simultaneous fractures History of mental disorder (based on medical record) Drug addiction M80.05 Age-related osteoporosis with current pathological fracture, femur Treatment - Drugs Treatment - Other Intervention group: Ultrasound-guided femoral nerve block (eZono AG/D-07743 Jena, Germany) will be performed before spinal anesthesia as 15 ml of ropivacaine 0.2% (made by MOLTEN) + 0.5 ml of magnesium sulfate 50% (made by Shahid Ghazi Tabriz). Control group: Ultrasound-guided femoral nerve block (eZono AG/D-07743 Jena, Germany) will be performed before spinal anesthesia as 15 ml of ropivacaine 0.2% (made by MOLTEN) + 0.5 ml of normal saline (made by Shahid Ghazi Tabriz). Determination of postoperative analgesia in Femoral fracture surgeries. Timepoint: Immediately after surgery, 6, 12 and 24 hours after surgery. Method of measurement: Visual analog scale of pain. Zanjan University of Medical Sciences Approved 2021-10-13 Ethics committee of Zanjan University of Medical Sciences Vice-Chancellor for Research and Technology, 3th Floor, 2th Bldg., Zanjan University of Medical Sciences, Azadi Blvd. Zanjan, IRAN. Zanjan Zanjan Iran (Islamic Republic of)