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IRCT20231025059847N1 IRCT 2023-11-09 Tehran University of Medical Sciences Investigating the analgesia effect of pudendal block with placebo after pelvic floor prolapse surgeries Comparison of the analgesia effect of perineal nerve blockage with marcaine with placebo after pelvic floor prolapse surgeries 2023-11-11 anticipated 25 Complete https://irct.ir/trial/73389 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study has two arms. First arm: pudendal block with marcaine. The second arm is the control group with placebo. In this study, random allocation will be done, the type of random allocation is block and the randomization unit is individual. Blocks of 4 will be used for random allocation. The randomization tool is the following online software: https://www.sealedenvelope.com/simple-randomiser/v1/lists Therefore, people will be randomly placed in one of two groups. In this study, due to the fact that the intervention is determined for the surgeon and the patient and is an open-label trial, blinding is not possible, but the analyzers of A and B will be blinded. Concealment will be done in the study, Blinding description: Blinding: the researcher who performs the analysis at the end is unaware of the allocation of the groups. So the study is one-side blind. The patient side is not blind. 2-3 Pelvic floor prolapse surgeries. Intervention 1: Intervention group: Women undergoing pelvic floor prolapse surgery, 30-80 years old, for whom pudendal block is performed as follows: 2 cc of Marcaine 7.5 mg/ml aspen group of companies inside the vagina, 1 cm lateral and behind the ischial spines. Intervention 2: Control group: Women undergoing pelvic floor prolapse surgery, 30-80 years old, for whom normal saline is administered in the same way as pudendal block after surgery: 2 cc of normal saline 0.9% inside the vagina, 1 cm lateral and behind the ischial spines. Yes - There is a plan to make this available What will be shared: After unrecognizing the participants, patient's demographic data, study protocol and main outcome information will be shared. When: The access period starts 3 months after the results are published To whom: All doctors and researchers working in the field of obstetrics and gynecology Conditions: Any data analysis and use of documents in the field of obstetrics and gynecology is allowed Where to obtain: The email address of the project manager: Hamide Nematian hnematian6173@gmail.com How to obtain: Email to the project manager and receive the required data within a month Comments:
public Hamide Nematian
Imam Khomeini hospital complex, Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1419733134 +98 21 6119 0000 hnematian6173@gmail.com Tehran University of Medical Sciences scientific Tahereh Eftekhar
Imam Khomeini hospital complex, Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1419733134 +98 21 6119 0000 eftkhart@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Women undergoing pelvic floor prolapse surgery 30 years 80 years Female History of chronic pelvic pain History of hypersensitivity to blocking drugs, narcotics or analgesics Chronic use of analgesics or narcotics Patients suffering from liver or kidney problems Patients with simultaneous abdominal or laparoscopic surgery N81.2 Incomplete uterovaginal prolapse Treatment - Drugs Placebo Intervention group: Women undergoing pelvic floor prolapse surgery, 30-80 years old, for whom pudendal block is performed as follows: 2 cc of Marcaine 7.5 mg/ml aspen group of companies inside the vagina, 1 cm lateral and behind the ischial spines. Control group: Women undergoing pelvic floor prolapse surgery, 30-80 years old, for whom normal saline is administered in the same way as pudendal block after surgery: 2 cc of normal saline 0.9% inside the vagina, 1 cm lateral and behind the ischial spines. Pain level after surgery. Timepoint: The day after the surgery. Method of measurement: Visual analogue scale. Nausea. Timepoint: The day after the surgery. Method of measurement: Asking the patient how often she feels nausea. Number of analgesics used. Timepoint: The day after the surgery. Method of measurement: Checking the number of analgesics requests in the file. Hamide Nematian Approved 2023-10-10 Ethics committee of Tehran University of Medical Sciences, Imam Khomeini hospital complex Imam Khomeini Hospital Complex, Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)