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IRCT20120910010800N11 IRCT 2023-05-06 Shahid Beheshti University of Medical Sciences Effect of celecoxib on pain after orthopedic surgery Comparing the preventive effect of celecoxib on pain after ankle fracture surgery 2023-05-10 anticipated 55 Complete https://irct.ir/trial/67159 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At the time of admission to the orthopedic department, the patients will be randomized using the permutation block method using random numbers obtained from the table of random numbers written on the card, which will be placed in sealed non-transparent envelopes, by an anesthesia technician who is in the stages. Next, there will be no interference plan, they will be placed equally in one of the following groups. Patients in the control group will receive two placebo capsules the night before surgery and one placebo capsule one hour before surgery. Group 400 patients will receive two celecoxib 200 mg capsules the night before surgery and one placebo capsule one hour before surgery. Group 600 patients will receive two 200 mg celecoxib capsules the night before the operation and another 200 mg celecoxib capsule one hour before the operation, Blinding description: In this study, 200 mg celecoxib capsules and placebo capsules will be used, in which the celecoxib content of the capsule is replaced with an approved artificial sweetener powder. These capsules will be placed inside the envelope during the preparation of the groups' envelopes and will be given to the patient by the ward nurse (the night before the operation) and the anesthesia technician (when entering the operating room), who will not be aware of the patient's next condition. The next follow-up of the patients and data recording will be done by the anesthesiologist who is not aware of the patient group. 3 Bimalleolar fracture of lower leg. Intervention 1: Intervention group: Patients in the 400 group will receive two celecoxib 200 mg capsules the night before surgery and one placebo capsule one hour before surgery. Intervention 2: Intervention group: Group 600 patients will receive two 200 mg celecoxib capsules the night before the operation and another 200 mg celecoxib capsule one hour before the operation. Intervention 3: Control group: Patients in the placebo group will receive two placebo capsules the night before the operation and another placebo capsule one hour before the operation. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. When: One year after the publication of the article. To whom: All jobs Conditions: All non-personal patient information (anonymously) can be accessed by contacting the responsible author. Where to obtain: Email to: drdariushabtahi@yahoo.com How to obtain: Sending email and review by the responsible author Comments:
public Dariush Abtahi
Emam Hossein Hospital, Shahid Madani St
Tehran Iran (Islamic Republic of) 1617763141 +98 21 2263 2611 d.abtahi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Dariush Abtahi
Emam Hossein Hospital, Shahid Madani St
Tehran Iran (Islamic Republic of) 1617763141 +98 21 2263 2611 d.abtahi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Over than 18 years old Consent to the study 18 years no limit Both Substance abuse Uncontrolled underlying disease Underlying neuropathy S82.84 Bimalleolar fracture of lower leg Treatment - Drugs Treatment - Drugs Placebo Intervention group: Patients in the 400 group will receive two celecoxib 200 mg capsules the night before surgery and one placebo capsule one hour before surgery. Intervention group: Group 600 patients will receive two 200 mg celecoxib capsules the night before the operation and another 200 mg celecoxib capsule one hour before the operation. Control group: Patients in the placebo group will receive two placebo capsules the night before the operation and another placebo capsule one hour before the operation. Postoperative pain. Timepoint: 6, 24 and 72 hours after the operation. Method of measurement: Using Visual Analogue Scale. Postoperative nausea and vomiting. Timepoint: 6, 24, and 72 hours after surgery. Method of measurement: Patient's statement. Shahid Beheshti University of Medical Sciences Approved 2023-04-30 Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me Next to Ayatollah Taleghani Hospital, Yemen Street, Shahid Arabi Street, Shahid Chamran Highway, Tehran Tehran Tehran Iran (Islamic Republic of)