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IRCT20220126053835N1 IRCT 2022-08-08 Esfahan University of Medical Sciences Effect of intraarterial lidocaine on post uterine fibroma embolization pain The evaluation of intraarterial lidocaine injection during uterine artery embolization on the reduction of post-embolization pain 2022-07-06 anticipated 50 Complete https://irct.ir/trial/61607 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients who meet the study criteria will enter the study through simple convenience sampling. A simple randomization method with individual blocks will be applied in the current study using blinded envelopes. Accordingly, each envelope contains a number about which the patient and the person who will gather the data will be blinded, and the patient will be allocated to one of the case versus control groups considering the number in the envelope. If the number is odd, the patient will be allocated to the intervention group and, if even, to the case group, Blinding description: Due to the anesthesia of the participants, they will be blinded to the performed arterial intervention for them. Albeit, they will get aware of the procedures in advance of the interventions and will sign a written consent. The statistical analyzer will be blinded, as well, because the data will be provided to him as group 1 and 2. 2-3 Post-uterine artery embolization pain. Intervention 1: Intervention group: The patients will be sedated with 5 mg midazolam and the embolization process will be initiated. The standard embolization protocol will be applied in which a 5 f catheter will be used to embolize through internal iliac artery by an expert interventionist. The embolization will be performed using polyvinyl alcohol entering through the horizontal part of uterine artery by a microcatheter. During the process of embolization, 5 cc lidocaine 1% (50 mg) will be injected. Intervention 2: Control group: The patients will be sedated with 5 mg midazolam and the embolization process will be initiated. The standard embolization protocol will be applied in which a 5 f catheter will be used to embolize through internal iliac artery by an expert interventionist. The embolization will be performed using polyvinyl alcohol entering through the horizontal part of the uterine artery by a microcatheter. The control group will not recieve any other injection. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying the participants When: The data might be accessible within 6 months after the article publication To whom: The university teachers can access the data Conditions: the data might be accessible for the future researches and through official requests. Where to obtain: The author who is responsible for the study should be emailed. Dr. Reza Tabibian Srt_1371@yahoo.com How to obtain: If the person who requires data would email the author and represent the proposal of the study and the organization who is responsible for the study performance would be clear, the data are accessible. Comments:
public Reza Tabibian
No.30, 12 Ave, south Farsan street
Isfahan Iran (Islamic Republic of) 8196837960 +98 31 3250 6157 srt_1371@yahoo.com Esfahan University of Medical Sciences scientific Reza Tabibian
No.30, 12 Ave, south Farsan street
Isfahan Iran (Islamic Republic of) 8196837960 +98 31 3250 6157 srt_1371@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) The patients with confirmed leiomyoma by ultrasonography Being in the childbearing ages Being the candidate of uterine artery embolization according to the opinion of obstetrician and gynecology specialist 20 years 50 years Female The patients with medical history of hypersentivity to pethidine, morphine, lidocaine and contrast agents The history of cardiac arrhythmia The presence of active pelvic inflammatory disease Treatment - Drugs N/A Intervention group: The patients will be sedated with 5 mg midazolam and the embolization process will be initiated. The standard embolization protocol will be applied in which a 5 f catheter will be used to embolize through internal iliac artery by an expert interventionist. The embolization will be performed using polyvinyl alcohol entering through the horizontal part of uterine artery by a microcatheter. During the process of embolization, 5 cc lidocaine 1% (50 mg) will be injected. Control group: The patients will be sedated with 5 mg midazolam and the embolization process will be initiated. The standard embolization protocol will be applied in which a 5 f catheter will be used to embolize through internal iliac artery by an expert interventionist. The embolization will be performed using polyvinyl alcohol entering through the horizontal part of the uterine artery by a microcatheter. The control group will not recieve any other injection. Postoperative pain. Timepoint: 2, 4, 6 and 8 hours after the operation. Method of measurement: Visual Analogue Scale. The applied pethidine dosage for pain controlling. Timepoint: 2, 4, 6 and 8 hours after the operaion. Method of measurement: According to the medical records (mg). Esfahan University of Medical Sciences Approved 2020-12-04 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)