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IRCT20190325043107N27 IRCT 2022-04-15 Tabriz University of Medical Sciences Adrenalized methylene blue and adrenalized Marcaine in pain relief after haemorrhoidectomy Comparison of the effect of adrenalized methylene blue and adrenalized Marcaine in pain relief after haemorrhoidectomy 2022-05-05 anticipated 100 Complete https://irct.ir/trial/62924 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the block random division method (4 blocks) is used. One of the study partners, for whom no blinding was performed, named the method of treatment of adrenalized methylene blue with the letter A and the method of treatment of adrenalized marcaine with the letter B. The researcher then distributes packages A and B among the patients referred to participate in the study by block random division method (4). Then, from the created blocks, enough blocks are randomly selected to reach the required sample size. To make a random sequence, we give possible blocks (6 blocks) from one to 6 numbers. Depending on the sample size, any number of 4 blocks that are needed will be used. Select the number of blocks from the table of random numbers and based on these numbers, the sequence of blocks in each group will be determined, Blinding description: The statistical consultant of this project will be unaware of the type of grouping of participants; The final results will be delivered to the statistical consultant. As the statistical consultant will not be in the process of grouping the participants; Therefore, he is blind during the study. 2-3 Pain. Intervention 1: Intervention group: Fifty patients will be included in this study after random allocation. After surgery,adrenalinez methylene blue (manufactured by Obaidi) will be injected into the operated area. Pain intensity will be measured for 12 hours after surgery using a VAS instrument. Intervention 2: Intervention group: Fifty patients will be included in this study after random allocation. After the surgery, adrenalinez marcaine (made by Obaidi company) will be injected in the operated area. Pain intensity will be measured for 12 hours after surgery using a VAS instrument. 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 more information
public Mohammadreza Dashti
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 dashti_mmr@gmail.com Tabriz University of Medical Sciences scientific Ramin Azhogh
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 Azhogh_r@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Candidate for hemorrhoidectomy surgery Satisfaction to participate in the study 18 years 75 years Both Patients with drug addiction Patients with anal infection Patients with irritable bowel syndrome Patients with perianal fistula G89.11 Acute pain due to trauma Treatment - Drugs Treatment - Drugs Intervention group: Fifty patients will be included in this study after random allocation. After surgery,adrenalinez methylene blue (manufactured by Obaidi) will be injected into the operated area. Pain intensity will be measured for 12 hours after surgery using a VAS instrument. Intervention group: Fifty patients will be included in this study after random allocation. After the surgery, adrenalinez marcaine (made by Obaidi company) will be injected in the operated area. Pain intensity will be measured for 12 hours after surgery using a VAS instrument. Pain. Timepoint: Before intervention and after intervention for twelve hours (once every hour). Method of measurement: VAS pain intensity measuring instrument. Tabriz University of Medical Sciences Approved 2022-04-06 Ethics committee of Tabriz University of Medical Sciences Imam Reza Hospital, Azadi Ave Tabriz East Azarbaijan Iran (Islamic Republic of)