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IRCT201404279014N34 IRCT 2014-05-03 Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Effect of epidural saline washout versus receiving nothing on regression of sensory and motor block after epidural anesthesia with Marcaine 0.5% and fentanyl in gynecologic surgery Effect of epidural saline washout versus receiving nothing on regression of sensory and motor block after epidural anesthesia with Marcaine 0.5% and fentanyl in gynecologic surgery: a double blinded randomized clinical trial 2012-12-21 anticipated 72 Complete https://irct.ir/trial/9473 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization: The first patient will be randomly assigned to intervention and control group using random number table. Then, other patients in order will be randomly assigned to either of the two groups. Blinding: The patients will be unaware of the intervention during surgery. In addition, the physician, who conduct the intervention is different from the physician who will examine the patients and the examiner will not be aware of the intervention. Therefore, the trial will be run as double blinded. 2 Condition 1: Cystocele. Condition 2: Rectocele. Intervention 1: infusion of 30 ml normal saline single dose through epidural catheter after surgery. Intervention 2: receive nothing.
public Dr Yaser Amirabadi
Beasat Hospital, Shahed Square, Behesh Ave.
Hamadan Iran (Islamic Republic of) +98 81 1264 0040 dr.amirabadi@yahoo.com Beasat Hospital scientific Dr Ahmad Moradi
Beasat Hospital, Shahed Square, Behesh Ave.
Hamadan Iran (Islamic Republic of) +98 81 1264 0040 dr.moradi_46@yahoo.com Beasat Hospital Iran (Islamic Republic of) Inclusion criteria: (a); candidate for cystocele or rectocele; (b) Having ASA class I or II. Exclusion criteria: (a) having intracranial pressure; (b) having hemodynamic disorder. no limit no limit Female N81.1 N81.6 Cystocele Rectocele Treatment - Drugs Placebo infusion of 30 ml normal saline single dose through epidural catheter after surgery receive nothing Assessing regression of sensory block. Timepoint: every 10 min immediately after operation until regression to 2 or 3 segments. Method of measurement: using cotton soaked in alcohol and pin prick. Assessing regression of motor block. Timepoint: every 10 min immediately after operation until regression to 1 or 2 score. Method of measurement: using Bromage scoring scale. Assessing post operational pain. Timepoint: immediately after surgery and 30 min, 1, 2, 6, and 12 hours later. Method of measurement: using VAS scoring scale. Mean arterial pressure. Timepoint: immediately after surgery and 30 min, 1, 2, 6, and 12 hours later. Method of measurement: using manometer. Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Approved 2014-03-10 Research Ethic Committee of Hamadan University of Medical Sciences Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Iran (Islamic Republic of)