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IRCT20230502058057N1 IRCT 2023-10-18 Islamic Azad University Effect of a single prophylactic dose of pregabalin on pain management and opioid requirement after cerebrocystectomy The Effect of Single Prophylactic Dose of Pregabalin on Pain Management and Opioids After Cholecystectomyin Patients Referred to Bo Ali Hospital in Tehran 2023-10-11 anticipated 80 Complete https://irct.ir/trial/69927 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, with a sample size of 80, we use the patients using the block permutation randomization method, which is used in this method to balance the number of allocated samples, and with 4 people in each block. We assemble the possible blocks as follows. block 1:BBAA and block 2:AABB and block 3:ABAB and block 4:BABA and block 5:ABBA and block6:BAAB we need 20 blocks for 80 people, these blocks are random in the software environment (version 2.0 (RandomAlloc.exe)) allocation software will be defined so that the number of 20 blocks of 4 will be defined in this software, this software is capable of generating a random sequence using the block method, then we choose from numbers one to six; For example, if number 6 is chosen as the first block and number 2 as the second block, the people who enter the study will be given BAABAABB in order from left to right, and finally to two intervention groups (group A) and group Control (group B) were divided, Blinding description: The thesis results analyst who analyzed the expected outcome and also the participants remained unaware of the type of procedure performed and were blind during the study; Therefore, this study was conducted in a double-blind manner. 2-3 Pain. Intervention 1: Intervention group: Pregabalin 300 mg tablets will be taken orally with a glass of water one hour before surgery, and pain intensity will be measured using the VAS instrument for six hours after surgery (once every hour). Intervention 2: Control group: PPlacebo tablets (same color and size as pregabalin tablets) will be taken orally with a glass of water one hour before surgery, and pain intensity will be measured using a VAS tool for six hours after surgery (once every hour). 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 further information.
public Bahram Davoudi
No. 2 , Mojahed St., Mojahedin Eslam Ave., Tehran Town
Tehran Iran (Islamic Republic of) 5981764863 +98 21 3344 0409 bahram.davoudi75@gmail.com Islamic Azad University scientific Bahram Davoudi
No. 2 , Mojahed St., Mojahedin Eslam Ave., Tehran Town
Tehran Iran (Islamic Republic of) 5981764863 +98 21 3344 0409 bahram.davoudi75@gmail.com Islamic Azad University Iran (Islamic Republic of) Laparoscopic cholecystectomy surgery candidate Class I and II according to ASA Consent to participate in the study 18 years 65 years Both Hypersensitivity to pregabalin Converting surgery from laparoscopy to open surgery Body mass index greater than 40 G89.11 Acute pain due to trauma Prevention Prevention Intervention group: Pregabalin 300 mg tablets will be taken orally with a glass of water one hour before surgery, and pain intensity will be measured using the VAS instrument for six hours after surgery (once every hour). Control group: PPlacebo tablets (same color and size as pregabalin tablets) will be taken orally with a glass of water one hour before surgery, and pain intensity will be measured using a VAS tool for six hours after surgery (once every hour). Pain. Timepoint: Once every hour for six hours after surgery. Method of measurement: Visual Analogue Scale. Islamic Azad University Approved 2023-02-20 Research Ethics Committees of Tehran Islamic Azad University Of Medical Sciences No 2, mojahed street, mojahedin eslam ave.,shohada sq.,District 12, tehran Tehran Tehran Iran (Islamic Republic of)