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IRCT20231130060227N1 IRCT 2025-10-23 Tehran University of Medical Sciences Comparison of the effects of intravenous dexmedetomidine and the local perineural combination of dexmedetomidine and ropivacaine on the duration of interscalene block and hemodynamic parameters in patients undergoing shoulder surgery Comparison of the effects of intravenous dexmedetomidine and the local perineural combination of dexmedetomidine and ropivacaine on the duration of interscalene block and hemodynamic parameters in patients undergoing shoulder surgery 2025-09-23 anticipated 64 Complete https://irct.ir/trial/84080 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided equally into 2 groups using the Block Randomization method. In this way, the treatment order was determined from the different states of the 4-blocks (AABB, ABAB, BBAA, BABA, BAAB, ABBA) randomly using a random number table and the placement of the 4-blocks in each list in such a way that there are no structural differences in the medical and demographic records of the patients in the groups, Blinding description: Patients participating in the study are informed about the drug injection during the interscalene block, and these patients are blinded to the type of drug injected during the interscalene block. The researcher is fully aware of the type of substance injected into each patient and is not blinded. N/A Study on the rate of motor block and postoperative pain in patients undergoing shoulder surgery.. Intervention 1: First Intervention group: Received dexmedetomidine 5mcg/kg with 30cc ropivacaine 0.5% perineural. Intervention 2: Second Intervention group: Received dexmedetomidine 5mcg/kg intravenously with 30cc ropivacaine 0.5% perineural. Intervention 3: Control group: Received 30cc ropivacaine 0.5% perineural. Yes - There is a plan to make this available What will be shared: Study data can be shared after being de-identified. When: Use of study data will be available for at least one year after publication of study results. To whom: All anesthesiologists and pain specialists will have access to the data. Conditions: Data analysis and use of results by orthopedic specialists will also be available. Where to obtain: To access the database, please contact the person responsible for the study, Dr. Hamed Abdollahi. How to obtain: The documents and data will be accessible according to the specified timeframe and upon formal request from academic and non-academic research centers. Comments:
public Hamed Abdollahi
Faculty of medicine, Poursina Avenue, Quds Avenue, Enghelab boulevard
Tehran Iran (Islamic Republic of) 1461884513 +98 21 6672 7060 hamiralam@sina.tums.ac.ir Tehran University of Medical Sciences scientific Hamed Abdollahi
Faculty of medicine, Poursina Avenue, Quds Avenue, Enghelab boulevard
Tehran Iran (Islamic Republic of) 1461884513 +98 21 6672 7060 hamiralam@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients age between 18 to 75 years old Patients undergoing elective shoulder surgery Patients with ASA class one and two 18 years 75 years Both Known Allergy to local anesthetic drugs Presence any kinds of neurologic, vascular and neuromuscular diseases Presence of hematologic and coagulation abnormalities Chronic opioid usage (more than six months) Treatment - Drugs Treatment - Drugs Placebo First Intervention group: Received dexmedetomidine 5mcg/kg with 30cc ropivacaine 0.5% perineural Second Intervention group: Received dexmedetomidine 5mcg/kg intravenously with 30cc ropivacaine 0.5% perineural Control group: Received 30cc ropivacaine 0.5% perineural Duration of Interscalen block. Timepoint: The duration of sensory block is determined from the onset of the block (confirmed by pinprick testing) until the return of sensation. The duration of motor block is determined from the onset of the block (confirmed by loss of muscle force) until the return of full force. Method of measurement: The variables are based on sensory clinical examination (pinprick test) and motor clinical examination (muscle force test). Tehran university of medical sciences Approved 2017-10-29 Ethics committee of Tehran University of Medical Sciences Shariati Educational, Research and Treatment Center, opposite the Faculty of Economics, Jalal Al-Ahmad Intersection, North Kargar Street, Tehran Tehran Tehran Iran (Islamic Republic of)