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IRCT20121216011766N7 IRCT 2021-06-21 Vice chancellor for research of Guilan University of Medical Sciences Axillary network block under ultrasound guide in upper limb trauma surgery Comparison of the success rate of axillary network block with 0.25% bupivacaine injection with or without dexamethasone, under ultrasound guide in upper limb trauma surgeries 2021-05-05 anticipated 72 Complete https://irct.ir/trial/55383 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All eligible individuals will be divided into intervention and control groups using block randomization method with 4 and 6 block sizes. To generate a randomization list from the online randomization service Sealed Envelope Ltd. 2019 was used (https://www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: Participants and the researcher collecting information will not be informed about the type of therapy received for each group in a double-blind manner, and each of the two types of treatment will be sent to therapists in a sealed envelope. 3 Control of acute pain after upper limb surgery. Intervention 1: Intervention group: group of Bupivacaine injection 0.25% with dexamethasone: All nerve blocks (brachial axillary network) will be performed by the anesthesiologist in charge, using the M7 model ultrasound device with a 10 megahertz transformer (linear probe). Oxygen will be prescribed for all patients 6 Litre per minute with the mask. standard monitoring (pulse oximetry, ECG, and Blood pressure) will be performed. The patient will be in the supine position while the shoulder is abducted and the elbow in the same hand is flexed. With sterility, under direct ultrasound vision, while the linear probe is located as a short axis in the axillary region, the musculocutaneous nerve and the axillary artery will be seen. Then, using the nerve block needle No. 22, with a length of 5 centimeters, Arrow model, and in-plane technique, we enter from the lateral to the medial. First, 30 milliliters of 0.25% bupivacaine plus 2 milliliters of dexamethasone (8 milligrams) will be injected into the nerve of the musculoskeletal nerve and then into the median, radial, and ulnar nerves. After ensuring the patients' analgesia, the orthopedist will be allowed to perform the surgery. Midazolam 0.02 milligrams per kilogram is prescribed to all patients for sedation before the blockade. Fentanyl 0.5 macrogramms per kilograms is also given to prevent tourniquet pain. Intervention 2: Control group: Injection group of bupivacaine 0.25% without dexamethasone: All nerve blocks (brachial axillary network) will be performed by the anesthesiologist in charge, using the M7 model ultrasound device with a 10 megahertz transformer (linear probe). Oxygen will be prescribed for all patients 6 Litre per minute with the mask. standard monitoring (pulse oximetry, ECG, and Blood pressure) will be performed. The patient will be in the supine position while the shoulder is abducted and the elbow in the same hand is flexed. With sterility, under direct ultrasound vision, while the linear probe is located as a short axis in the axillary region, the musculocutaneous nerve and the axillary artery will be seen. Then, using the nerve block needle No. 22, with a length of 5 centimeters, Arrow model, and in-plane technique, we enter from the lateral to the medial. First, 30 milliliters of 0.25% bupivacaine plus 2 milliliters of Sterile water will be injected into the nerve of the musculoskeletal nerve and then into the median, radial, and ulnar nerves. After ensuring the patients' analgesia, the orthopedist will be allowed to perform the surgery. Midazolam 0.02 milligrams per kilogram is prescribed to all patients for sedation before the blockade. Fentanyl 0.5 macrogramms per kilograms is also given to prevent tourniquet pain. 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 Not decided yet
public Hossein Khoshrang
Razi Hospital
Rasht Iran (Islamic Republic of) 4139638459 +98 13 3336 8534 arcguilan1392@gmail.com Anesthesiology Research Center scientific Hossein Khoshrang
Razi Hospital
Rasht Iran (Islamic Republic of) 4139638459 +98 13 3336 8534 arcguilan1392@gmail.com Anesthesiology Research Center Iran (Islamic Republic of) Patients with upper limb trauma, candidates for elective upper limb surgery Age over 18 years ASA class I-III 18 years no limit Both Diabetes Drug addiction Sepsis Infection of injection site Sensitivity to local anesthetics Coagulation disorder Kidney or liver failure History of previous weakness and paresis in the operation area History of axillary surgery G89.11 Acute pain due to trauma Treatment - Drugs Placebo Intervention group: group of Bupivacaine injection 0.25% with dexamethasone: All nerve blocks (brachial axillary network) will be performed by the anesthesiologist in charge, using the M7 model ultrasound device with a 10 megahertz transformer (linear probe). Oxygen will be prescribed for all patients 6 Litre per minute with the mask. standard monitoring (pulse oximetry, ECG, and Blood pressure) will be performed. The patient will be in the supine position while the shoulder is abducted and the elbow in the same hand is flexed. With sterility, under direct ultrasound vision, while the linear probe is located as a short axis in the axillary region, the musculocutaneous nerve and the axillary artery will be seen. Then, using the nerve block needle No. 22, with a length of 5 centimeters, Arrow model, and in-plane technique, we enter from the lateral to the medial. First, 30 milliliters of 0.25% bupivacaine plus 2 milliliters of dexamethasone (8 milligrams) will be injected into the nerve of the musculoskeletal nerve and then into the median, radial, and ulnar nerves. After ensuring the patients' analgesia, the orthopedist will be allowed to perform the surgery. Midazolam 0.02 milligrams per kilogram is prescribed to all patients for sedation before the blockade. Fentanyl 0.5 macrogramms per kilograms is also given to prevent tourniquet pain. Control group: Injection group of bupivacaine 0.25% without dexamethasone: All nerve blocks (brachial axillary network) will be performed by the anesthesiologist in charge, using the M7 model ultrasound device with a 10 megahertz transformer (linear probe). Oxygen will be prescribed for all patients 6 Litre per minute with the mask. standard monitoring (pulse oximetry, ECG, and Blood pressure) will be performed. The patient will be in the supine position while the shoulder is abducted and the elbow in the same hand is flexed. With sterility, under direct ultrasound vision, while the linear probe is located as a short axis in the axillary region, the musculocutaneous nerve and the axillary artery will be seen. Then, using the nerve block needle No. 22, with a length of 5 centimeters, Arrow model, and in-plane technique, we enter from the lateral to the medial. First, 30 milliliters of 0.25% bupivacaine plus 2 milliliters of Sterile water will be injected into the nerve of the musculoskeletal nerve and then into the median, radial, and ulnar nerves. After ensuring the patients' analgesia, the orthopedist will be allowed to perform the surgery. Midazolam 0.02 milligrams per kilogram is prescribed to all patients for sedation before the blockade. Fentanyl 0.5 macrogramms per kilograms is also given to prevent tourniquet pain. Intensity of sensory block. Timepoint: After the anesthesia procedure, every 5 minutes along 30 minutes. Method of measurement: According to the Pinprick test: zero has a perfect sense, one a slight sense, two have no sense at all. Intensity of motor block. Timepoint: After the anesthesia procedure, every 5 minutes along 30 minutes. Method of measurement: According to the Modified Bromage Scale: zero inability to move fingers, one only being able to move fingers, two being able to move and bend the wrist, three full elbow flexions. Possible side effects of injecting medication. Timepoint: During the procedure till the end of the surgery. Method of measurement: Checking of of paraesthesia, incorrect intravascular injection, hematoma and nerve damage. Vice President of Research Guilan university of medical sciences Approved 2021-03-10 Ethics committee of Guilan University of Medical Sciences Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street,Rasht Rasht Guilan Iran (Islamic Republic of)