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IRCT20151107024909N10 IRCT 2020-05-19 Iran University of Medical Sciences Comparison of pectoral nerve block Vs field block in transsexual patients undergoing breast reconstruction surgery Comparison of pectoral nerve block Vs field block in transsexual patients undergoing breast reconstruction surgery 2020-05-20 anticipated 50 Complete https://irct.ir/trial/48192 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, a simple randomization method is used, which is done using a table of random numbers.To use the number of random numbers, we first determine the reading path of the table numbers (for example, top, bottom, left or right).Then we assume certain numbers for each group (for example, even numbers for intervention A and odd numbers for intervention B).Then we touch on one of the numbers and move in one of the predetermined directions and record the numbers and assign them to different groups, Blinding description: In this study, a person who is responsible for analyzing statistical data is not aware of the treatment process and study groups and the information is provided to that person in groups A and B. This helps the person's personal opinion not to affect the results. N/A breast reconstruction surgery. Intervention 1: Intervention group: After standard monitoring, patients are anesthetized with intravenous drugs. After the surgery, the patients are placed under a nerve block in one of two ways. In the pectoral nerve block group, after the surgery, the ultrasound probe is placed on the Infraclavicular area and moved to the artery and the axillary vein above the first rib to the outside just above the junction of the pectoralis major and minor muscles at the window location. The syringe is then inserted between the two muscles and 10 ml of ropivacaine ۰/۲% is injected to block the internal pectoral nerve as well as the external pectoral nerve . Intervention 2: Control group: After standard monitoring, patients are anesthetized with intravenous drugs. After the surgery, the patients are placed under a nerve block in one of two ways.In the second groop the nerve block is performed by the surgeon himself and in the final stages before the surgery. Before the skin is sutured, the surgeon injects 3 cc of Ropevacaine ۰/۲% in three spaces between the T3 and T5 ribs in each space, and the injection time is recorded. 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 further information
public Faranak Rokhtabnak
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
Tehran Iran (Islamic Republic of) 1433933111 +98 21 8894 6267 Rolhtabnak.f@iums.ac.ir Iran University of Medical Sciences scientific Faranak Rokhtabnak
Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town
Tehran Iran (Islamic Republic of) 1433933111 +98 21 8894 6267 rkhtbnk@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Transsexual patients with ASA I-II anesthesia score and candidate for mastectomy Age range between 18 and 50 years 18 years 50 years Female Age less than 18 years or older than 50 years Obesity History of pregnancy or lactation History of allergy to anesthetics History of hemorrhagic disease N65.0 Deformity of reconstructed breast Treatment - Other Treatment - Other Intervention group: After standard monitoring, patients are anesthetized with intravenous drugs. After the surgery, the patients are placed under a nerve block in one of two ways. In the pectoral nerve block group, after the surgery, the ultrasound probe is placed on the Infraclavicular area and moved to the artery and the axillary vein above the first rib to the outside just above the junction of the pectoralis major and minor muscles at the window location. The syringe is then inserted between the two muscles and 10 ml of ropivacaine ۰/۲% is injected to block the internal pectoral nerve as well as the external pectoral nerve . Control group: After standard monitoring, patients are anesthetized with intravenous drugs. After the surgery, the patients are placed under a nerve block in one of two ways.In the second groop the nerve block is performed by the surgeon himself and in the final stages before the surgery. Before the skin is sutured, the surgeon injects 3 cc of Ropevacaine ۰/۲% in three spaces between the T3 and T5 ribs in each space, and the injection time is recorded. The severity of the pain. Timepoint: After surgery. Method of measurement: VAS scoring system. Nausea. Timepoint: After surgery. Method of measurement: Patient comment. Vomiting. Timepoint: After surgery. Method of measurement: Patient comment. Iran University of Medical Sciences Approved 2020-05-11 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town Tehran Tehran Iran (Islamic Republic of)