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IRCT20220120053774N1 IRCT 2022-02-05 Sanandaj University of Medical Sciences The effect of adding dexamethasone to lidocaine in infraclavicular block on the onset and duration of block Evaluating the Effect of adding Dexamethasone to Lidocaine 1.5% in Infraclavicular Block with Ultrasound Guide on the Onset of Effect and Duration of Block 2022-03-21 anticipated 72 Complete https://irct.ir/trial/61625 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling will be done randomly using computer generated random numbers. Thus, each "odd number" produced belongs to group 1 ( intervention group) and each randomly generated "even number" belongs to group 2 (patient placement in the control group), Blinding description: To blind this study, patients do not know which study groups they are in. Also, the combination of lidocaine-dexamethasone solution or lidocaine-placebo, in the same volume of 36 ml, is prepared and coded by a nurse colleague who is not present in the study. The anesthesiologist who also performs the procedure is not aware of the prescription drug and the grouping of patients. Patients will be evaluated by an anesthesia assistant who is not in the study group. 3 Upper limb fractures. Intervention 1: Intervention group: 33 ml of 1.5% lidocaine solution (495 mg) and 2 ml of dexamethasone (Dexadic - Caspian Supply Pharmaceutical Company) (8 mg) will be used for Infraclavicular Block . Intervention 2: Control group: 33 ml of 1.5% lidocaine solution (495 mg) and 2 ml of normal saline (placebo) will be used for Infraclavicular Block . Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Farzad Sarshivi
Kowsar Hospital - Hamdi Blvd- Pasdaran Blvd
Sanandaj Iran (Islamic Republic of) 66177-13663 +98 87 3361 1231 farzadsarshivi@gmail.com Sanandaj University of Medical Sciences scientific Farzad Sarshivi
Kowsar Hospital - Hamdi Blvd- Pasdaran Blvd
Sanandaj Iran (Islamic Republic of) 66177-13663 +98 87 3361 1231 farzadsarshivi@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Age 18 to 60 years old ASA classification Status 1 and 2 Need to orthopedic surgery to repair an upper limb fracture (below the arm) 18 years 60 years Both Coagulation disorder (INR> 1.4) History of liver, kidney, peptic ulcer disease History of uncontrolled diabetes Infection in the area of nerve block History of hypersensitivity to local anesthetics or dexamethasone History of long-term use of corticosteroids History of addiction or narcotic use Pregnancy Changing the anesthesia plan during surgery from nerve block to general anesthesia Hemodynamic instability Patient request to leave the study S.52 Injuries to the elbow and forearm Treatment - Drugs Treatment - Surgery Intervention group: 33 ml of 1.5% lidocaine solution (495 mg) and 2 ml of dexamethasone (Dexadic - Caspian Supply Pharmaceutical Company) (8 mg) will be used for Infraclavicular Block . Control group: 33 ml of 1.5% lidocaine solution (495 mg) and 2 ml of normal saline (placebo) will be used for Infraclavicular Block . The onset of analgesia. Timepoint: Every 5 minutes to complete block. Method of measurement: Using a question from the patient and using a pinprick test, using a needle with mild skin irritation (normal sense of zero score, inability to understand pinprick score 1 and lack of sense of touch score 2) will be used. To ensure analgesia, a score of 1 sensory block is acceptable. The patient's sensory block is assessed and the patient's onset of analgesia is recorded in a questionnaire. Motion block is also measured using a modified bromage scale. In this way, points are given from zero to 4 (full strength of related muscles, score 4, decrease in muscle strength but the ability to move against resistance 3, ability to move against gravity 2, slight muscle jump 1 and inability to move zero score). The ِduration of analgesia. Timepoint: Every 5 minutes to 30 minutes after injection of block solution, during surgery and then every 30 minutes until complete removal of sensory and motor block in recovery and ward. Method of measurement: Pain in the recovery ward using the Visual Analogue Scale (VAS), which is a numerical scoring scale (zero painless to 10 highest pain). Sanandaj University of Medical Sciences Approved 2021-12-21 Research Ethics Committees of Kurdistan University of Medical Sciences Pasdaran Blvd Sanandaj Kurdistan Iran (Islamic Republic of)