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IRCT20090525001946N10 IRCT 2019-07-30 Rasht University of Medical Sciences The effect of injecting of lidocaine and adrenaline in myometrium on bleeding during myomectomy Evaluation of the effects of local- intra myometrial injection of lidocaine plus adrenaline in the amount of blood loss during myomectomy 2019-07-06 anticipated 60 Complete https://irct.ir/trial/40834 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To produce random sequences in this clinical trial, we will use this site: http://www.graphpad.com/quickcalcs/index.cfm. A nurse who is not in the study will do it. Patients with inclusion criteria will randomly be divided into 2 groups by quadruple block method: intervention (lidocaine and adrenaline) and control, Blinding description: Medications and placebo will be prepared and coded by an anesthetic technician who does not participate in this study. All myomectomy cases will be performed by one surgeon with one surgical method. The same general anesthetic protocol will be considered for all patients. In this study, the patient and the surgeon, as well as the trained person who collects the information and reports bleeding, are unaware of the type of treatment group and BLIND. 3 Bleeding during myomectomy. Intervention 1: Intervention group: In the treatment group, before the removal of the myoma, and after monitoring is done by the anesthetic team, 40 milliliters of the local anesthetic solution containing lidocaine 2% (3 milligrams per kilograms) + adrenaline 0.5 milliliters (from vial 1 milligram/milliliter) will be injected around Myoma and myometrium. Intervention 2: Control group: In the control group, before the removal of the myoma, and after monitoring is done by the anesthetic team, 40 milliliters of normal saline will be injected around Myoma and myometrium. 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 Mandana Mansur Ghanaie
Reproduction Health Research Center-Alzahra hospital-Namjo street
Rasht Iran (Islamic Republic of) 4144654839 +98 13 1322 5624 m_m_ghanaie@gums.ac.ir Rasht University of Medical Sciences scientific Mandana Mansur Ghanaie
Reproduction Health Research Center-Alzahra hospital-Namjo street
Rasht Iran (Islamic Republic of) 4144654839 +98 13 1322 5624 m_m_ghanaie@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Women of reproductive age candidate for Myomectomy Patients with symptomatic Myoma without responding to medical treatments (laparotomy, infertility for more than 3 years with myomectomy indication) Pain and pelvic pressure Urination frequency and constipation The size of the uterus is less than 18 weeks. Not accepting hysterectomy Myoma grade 6-2 based on ultrasound The cause of myoma bleeding is detected no limit no limit Female Adenomyosis of cervical myomas or peduncle Coagulation problems and recurrent vascular thrombosis Ischemic heart disease, cardiomyopathy Women with multiple myomas Lidocaine susceptibility c Uncontrolled hypertension Hyperthyroidism Seizure Recent use of ergot alkaloids and vasoconstrictors, triangular antidepressants and monoamine oxidase inhibitors. Liver disease Diabetes, asthma, COPD Malignancy Prevention Placebo Intervention group: In the treatment group, before the removal of the myoma, and after monitoring is done by the anesthetic team, 40 milliliters of the local anesthetic solution containing lidocaine 2% (3 milligrams per kilograms) + adrenaline 0.5 milliliters (from vial 1 milligram/milliliter) will be injected around Myoma and myometrium Control group: In the control group, before the removal of the myoma, and after monitoring is done by the anesthetic team, 40 milliliters of normal saline will be injected around Myoma and myometrium The amount of bleeding of patients during myomectomy surgery. Timepoint: After the operation, according to the information recorded in the patient's file. Method of measurement: With the difference in hemoglobin (g / dl) before and after operation and the number of transfused blood pack cells during operation. Rasht University of Medical Sciences Approved 2019-06-12 Ethics Committee Of Guilan University Of Medical Sciences Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street Rasht Guilan Iran (Islamic Republic of)