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IRCT20151123025202N32 IRCT 2023-10-24 Hamedan University of Medical Sciences Prevention of hematoma, swelling and pain after carpal tunnel syndrome surgery with tranexamic acid Evaluation of the effect of topical tranexamic acid administration in preventing hematoma, swelling and pain after carpal tunnel syndrome surgery 2023-12-22 anticipated 52 Complete https://irct.ir/trial/73297 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: For this purpose, the block randomization method of 50 blocks will be used. In this block, each cells contains the letters RA-LB (meaning the right hand of drug A and the left hand of drug B) or RB-LA (the right hand of drug B). and the left hand of drug A) which are randomly distributed. With the referral of each of the qualified patients, one of the houses is randomly selected and according to whether it is RA-LB or RB-LA. Right and left hand medicine type will be selected. And the selected cell will be crossed with a red pen in order not to be selected again. Codes A and B (normal saline or tranexamic acid) will be revealed at the end of the study and after the analysis, Blinding description: Transgamic acid and normal saline will be drawn in syringes of the same color and shape with codes A and B by the operating room technician, and the codes will remain secret with this person until the end of the research. Therefore, the patient, the surgeon who will measure and record the outcome of the study, and the statistical consultant will will be blind about the contents of the syringe used, and the study will be performed in a triple blind manner. 3 Carpal tunnel syndrome. Intervention 1: Intervention group: After the completion of carpal tunnel syndrome surgery, two ampoules of tranexamic acid (2 grams) will be injected into the flexor sheet. Intervention 2: Control group: After the completion of carpal tunnel syndrome surgery, normal saline will be used inside the flexor sheet. Yes - There is a plan to make this available What will be shared: All data can be shared except for authors names When: From 2024 onwards it is permissible To whom: Clinical professionals and Researchers in all fields Conditions: To develop research and science Where to obtain: Correspond to the email address of the scientific responsible for the study How to obtain: Send and receive email Comments: No more information
public Abbas Moradi
Medicine School, Shahid Fahmideh Street, Hamadan
HamŲ«dan Iran (Islamic Republic of) 6517838736 +98 81 3838 0097 a.moradi@umsha.ac.ir Hamedan University of Medical Sciences scientific Bijan Heidari
Shahid Fahmide
Hamadan Iran (Islamic Republic of) 6517838736 +98 81 3838 0572 b.heidari@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Diagnosis of bilateral carpal tunnel syndrome that requires surgery Not using anti-anxiety, hypnotic and sedative drugs Hemoglobin >10 no limit no limit Both History of coagulopathy Allergy to tranexamic acid Contraindication for spinal anesthesia and allergy to anesthetics and other drugs. G56.0 Carpal tunnel syndrome Treatment - Drugs Placebo Intervention group: After the completion of carpal tunnel syndrome surgery, two ampoules of tranexamic acid (2 grams) will be injected into the flexor sheet. Control group: After the completion of carpal tunnel syndrome surgery, normal saline will be used inside the flexor sheet Hematoma. Timepoint: 24 hours, 2 weeks, 1 month and 3 months post operation. Method of measurement: Clinical Examination. Swelling. Timepoint: 24 hours, 2 weeks, 1 month and 3 months post operation. Method of measurement: Clinical Examination. Pain. Timepoint: 24 hours, 2 weeks, 1 month and 3 months post operation. Method of measurement: Visual Analogue Scale. Hamedan University of Medical Sciences Approved 2023-07-01 Ethics committee of Hamadan Univercity of Medical Science shahid fahmideh avenue Hamadan Hamadan Iran (Islamic Republic of)