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IRCT20141209020258N183 IRCT 2023-05-23 Vice chancellor for research, Arak University Of Medical Sciences The effect of rocuronium and nitroglycerin in reducing pain in intravenous local anesthesia Comparing the effect of adding rocuronium and nitroglycerin to ropivacaine in reducing pain and hemodynamic changes in intravenous local anesthesia 2023-06-05 anticipated 177 Complete https://irct.ir/trial/70178 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated into2 groups using a permuted balanced block randomization method with the size of blocks 4. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method, Blinding description: Interventional drugs will be prescribed by an anesthesiologist, but the Bear Block technique and checking the effects and recording data will be done by a specialist assistant who is not aware of the groupings. In this way, due to the lack of knowledge of the patient and the results evaluator about the order of the groups and interventions, the study will be double-blind. 2-3 Forearm fracture. Intervention 1: Intervention group: The nitroglycerin group will be injected with 200 micrograms of nitroglycerin (Iran Caspin Company) along with 0.2% ropivacaine. The volume of ropivacaine in all groups will be 35 ml (70 mg) and the desired dose of adjuvant drug will be increased to 5 ml with distilled water, and finally the total volume of drug injected in IVRA in each patient will be 40 ml from the venous cannula site in all groups. Intervention 2: Intervention group: The rocuronium(behsan daru) group will be injected with 0.06 mg/kg of rocuronium along with 0.2% ropivacaine. The volume of ropivacaine in all groups will be 35 ml (70 mg) and the intended dose of adjuvant drug will be increased to 5 ml with distilled water, and finally the total volume of drug injected in IVRA in each patient is 40 ml from the venous cannula site in all groups. Intervention 3: Control group: As an adjuvant, 5 ml of normal saline with 35 ml of 0.2% ropivacaine with a total volume of 40 ml will be injected through the venous cannula. 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 Dr Esmaeel Moshiri
Shahid Shirodi street, Valiasr square, Valiasr hospital
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences scientific Dr Hesamedin Modir
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) 20-65 years ASA class I and II Forearm surgery candidate Consent to enter the study Not having Raynaud's disease Not having sickle cell anemia No history of allergy to the drugs used in the study Absence of cyanosis of the affected organ No use of drugs and psychotropic substances No contraindications for intravenous anesthesia The absence of more than one fracture in the body or surgery Absence of chronic pain syndrome Absence of neurological disorders in the hand 20 years 65 years Both The duration of surgery is more than 90 minutes For any reason, the local intravenous anesthesia is terminated (ineffective) during the operation. The duration of the operation is less than 30 minutes M21.83 Other specified acquired deformities of forearm Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: The nitroglycerin group will be injected with 200 micrograms of nitroglycerin (Iran Caspin Company) along with 0.2% ropivacaine. The volume of ropivacaine in all groups will be 35 ml (70 mg) and the desired dose of adjuvant drug will be increased to 5 ml with distilled water, and finally the total volume of drug injected in IVRA in each patient will be 40 ml from the venous cannula site in all groups. Intervention group: The rocuronium(behsan daru) group will be injected with 0.06 mg/kg of rocuronium along with 0.2% ropivacaine. The volume of ropivacaine in all groups will be 35 ml (70 mg) and the intended dose of adjuvant drug will be increased to 5 ml with distilled water, and finally the total volume of drug injected in IVRA in each patient is 40 ml from the venous cannula site in all groups. Control group: As an adjuvant, 5 ml of normal saline with 35 ml of 0.2% ropivacaine with a total volume of 40 ml will be injected through the venous cannula. Pain. Timepoint: After filling the tourniquet, and at times 15, 30 and 45 and every 15 minutes until the end of the surgery, after emptying the tourniquet every 30 minutes up to 2 hours (minutes 30, 60, 90 and 120) and then every two hours until 12 hours (4, 6, 8, 10 and 12 hours) after emptying the tourniquet. Method of measurement: Visual analog scale of pain. Vice chancellor for research, Arak University Of Medical Sciences Approved 2023-05-01 Ethics Committe Arak University Of Medical Sciences Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)