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IRCT20170301032837N3 IRCT 2020-05-11 Iran University of Medical Sciences The effect of ultrasound guided intercostobrachial nerve block on tourniquet pain in axillary block The effect of ultrasound guided intercostobrachial nerve block on tourniquet pain in patients undergoing axillary block in soft arm and forearm surgery 2018-06-22 anticipated 60 Complete https://irct.ir/trial/45049 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple, individual randomization using random number table, so that the first patient was drawn by drawing lots in one of the three groups and the next patient was placed in one of the other two groups by using the table of random numbers based on even and odd numbers. And this sequence continued. Only the blocking researcher knew the random sequence, Blinding description: The participants in this study have no knowledge of the nerve block method and in which research group they belonged. The block was performed by the researcher and the evaluating researcher was not present in the room at the time of the block and another evaluates the outcomes without knowing which group the participant belongs to.Due to the fact that the intercostobrachial nerve block is performed during the axillary block, there is no apparent difference between patients after it is performed. N/A Tourniquet pain in axillary block. Intervention 1: Intervention group 1: ultrasound guided intercostobrachial nerve block group. In this group, after IV access and monitoring of vital signs, patients undergoing sedation with Midazolam 0.15 mg/kg and fentanyl 1.5 micrograms/kg and then is placed in a supine position with his upper extrimity 90 degree angle with the body.The axillary area and the medial part of the arm are then prepared with betadine solution and draped. Using sonography (S- Nerve Ultrasound, Sonosite, Inc. WA, USA) and nerve stimulator (Plexygon, VYGON, Inc. Italy) and needle number 21 (Locoplex, VYGON, France), at first four nerves of the median, ulna, radial, and musculoskeletal nerves are blocked, each with 7 cc of lidocaine 1.5 percent, and then the intercostobrachial nerve above the deep fascia are blocked with ultrasound and 2 cc of 1.5% lidocaine. Intervention 2: Intervention group 2: intercostobrachial nerve block without ultrasound group. In this group, after IV access and monitoring of vital signs, patients undergoing sedation with Midazolam 0.15 mg/kg and fentanyl 1.5 micrograms/kg and then is placed in a supine position with his upper extrimity 90 degree angle with the body. The axillary area and the medial part of the arm are then prepared with betadine solution and draped. Using sonography (S- Nerve Ultrasound, Sonosite, Inc. WA, USA) and nerve stimulator (Plexygon, VYGON, Inc. Italy) and needle number 21 (Locoplex, VYGON, France), first four nerves of the median, ulna, radial, and musculoskeletal nerves were blocked, each with 7 cc of 1.5% lidocaine, and then the intracostobrachial nerve was blocked without ultrasound and by the conventional method, by touching the pulse of the axillary artery and injection of 2 cc of 1.5% lidocaine, on the pulse of the artery and under the skin. Intervention 3: Control group: without intercostobrachial nerve block.In this group, after IV access and monitoring of vital signs, patients undergoing sedation with Midazolam 0.15 mg/kg and fentanyl 1.5 micrograms/kg and then is placed in a supine position with his upper extrimity 90 degree angle with the body. The axillary area and the medial part of the arm are then prepared with betadine solution and draped. Using sonography (S- Nerve Ultrasound, Sonosite, Inc. WA, USA) and nerve stimulator (Plexygon, VYGON, Inc. Italy) and needle number 21 (Locoplex, VYGON, France), four nerves of the median, ulna, radial, and musculoskeletal nerves are blocked, each with 7 cc of 1.5% lidocaine. The intercostobrachial nerve block is not performed in this group. Yes - There is a plan to make this available What will be shared: All data can be shared after people have not been identified. When: Start of access period from 1399 To whom: Researchers working in academic and scientific institutions Conditions: Academic and scientific researchers can use it for future researches. Where to obtain: zaman.b@iums.ac.ir How to obtain: Applicants should send the required request and explanation via e-mail to the registrant, which will be sent within a maximum of one month, if they meet the above requirements. Comments: For academic and scientific researchers, we will provide any assistance we can.
public Behrooz Zaman
Hazrat-e fatemeh hospital, 21st street, Asadabadi Ave
Tehran Iran (Islamic Republic of) 1433933111 +98 21 8871 7272 zaman.b@iums.ac.ir Iran University of Medical Sciences scientific Behrooz Zaman
Hazrat-e Fatemeh Hospital, 21st Street, Asadabadi Ave.
Tehran Iran (Islamic Republic of) 1433933111 +98 21 8871 7272 zaman.b@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age 20 - 50 Hand and forearm soft tissue surgery with a minimum operation time of 90 minutes ASA 1-2 Patients BMI between 23-28 Having the right cooperation and ability to communicate with the research team 20 years 50 years Both Drug Addiction History of seizures Coagulation problem Upper limb neuropathy Vasculitis Unstable hemodynamic Allergy to local anesthetics G89.1 Acute pain, not elsewhere classified Prevention Prevention Prevention Intervention group 1: ultrasound guided intercostobrachial nerve block group. In this group, after IV access and monitoring of vital signs, patients undergoing sedation with Midazolam 0.15 mg/kg and fentanyl 1.5 micrograms/kg and then is placed in a supine position with his upper extrimity 90 degree angle with the body.The axillary area and the medial part of the arm are then prepared with betadine solution and draped. Using sonography (S- Nerve Ultrasound, Sonosite, Inc. WA, USA) and nerve stimulator (Plexygon, VYGON, Inc. Italy) and needle number 21 (Locoplex, VYGON, France), at first four nerves of the median, ulna, radial, and musculoskeletal nerves are blocked, each with 7 cc of lidocaine 1.5 percent, and then the intercostobrachial nerve above the deep fascia are blocked with ultrasound and 2 cc of 1.5% lidocaine. Intervention group 2: intercostobrachial nerve block without ultrasound group. In this group, after IV access and monitoring of vital signs, patients undergoing sedation with Midazolam 0.15 mg/kg and fentanyl 1.5 micrograms/kg and then is placed in a supine position with his upper extrimity 90 degree angle with the body. The axillary area and the medial part of the arm are then prepared with betadine solution and draped. Using sonography (S- Nerve Ultrasound, Sonosite, Inc. WA, USA) and nerve stimulator (Plexygon, VYGON, Inc. Italy) and needle number 21 (Locoplex, VYGON, France), first four nerves of the median, ulna, radial, and musculoskeletal nerves were blocked, each with 7 cc of 1.5% lidocaine, and then the intracostobrachial nerve was blocked without ultrasound and by the conventional method, by touching the pulse of the axillary artery and injection of 2 cc of 1.5% lidocaine, on the pulse of the artery and under the skin. Control group: without intercostobrachial nerve block.In this group, after IV access and monitoring of vital signs, patients undergoing sedation with Midazolam 0.15 mg/kg and fentanyl 1.5 micrograms/kg and then is placed in a supine position with his upper extrimity 90 degree angle with the body. The axillary area and the medial part of the arm are then prepared with betadine solution and draped. Using sonography (S- Nerve Ultrasound, Sonosite, Inc. WA, USA) and nerve stimulator (Plexygon, VYGON, Inc. Italy) and needle number 21 (Locoplex, VYGON, France), four nerves of the median, ulna, radial, and musculoskeletal nerves are blocked, each with 7 cc of 1.5% lidocaine. The intercostobrachial nerve block is not performed in this group. Onset of pain of tourniquet. Timepoint: every 15 minutes. Method of measurement: Patient expression and Analogue Scale. Severity of tourniquet pain. Timepoint: every 15 minutes. Method of measurement: Visual Analogue Scale. Iran University of Medical Sciences Approved 2019-04-23 Ethics committee of Iran University of Medical Sciences Hemmat highway Tehran Tehran Iran (Islamic Republic of)