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IRCT20131020015083N5 IRCT 2024-02-07 Shiraz University of Medical Sciences Investigating the effect of Bupivacaine on post operative pain after rhinoplasty Investigating the effect of injectable and topical Bupivacaine on post operative pain after rhinoplasty 2024-02-20 anticipated 50 Complete https://irct.ir/trial/75276 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Participants were randomly assigned to injection (number 0 in select case) or topical (number 1 in select case), combined (number 2 in select case), and control (number 3 in select case) groups (1:1:1:1 ratio) using random numbers which were generated through computerized block randomization using SPSS software version 23. To reduce selection bias and confounding factors, randomization was performed by a single appointed researcher who did not participate in data collection, Blinding description: Participant, Care provider, Investigator, Outcome assessor, Data analyser, and Data and Safety Monitoring Board were unaware of the intervention and allocation of treatments until the statistical analysis was complete. 3 patients underwent rhinoplasty. Intervention 1: patients who at the end of the operation (before the patient regains consciousness) will be injected with bupivacaine (Marcaine® 0.5%: Aspen Japan; Tokyo, Japan) with a total volume of 4 ml as a local anesthetic. Intervention 2: Intervention group:There are patients who will be administered local anesthetic bupivacaine (Marcaine® 0.5%: Aspen Japan; Tokyo, Japan) with a total volume of 4 ml at the beginning of the procedure. Intervention 3: Intervention group: There are patients who receive local bupivacaine through the mesh (each mesh 1 cc, 2 cc in total) at the beginning of the procedure and bupivacaine injection (0.5 cc in each point, 2 cc in total) at the end of the procedure (a total of 4 cc of bupivacaine). Intervention 4: Control group: No local anesthesia will be used. Yes - There is a plan to make this available What will be shared: all collected deidentified IPD When: sarting 6 months after publication To whom: only available for people working in academic institutions. Conditions: there is no specified criteria Where to obtain: corresponding author (09177395073, babaei@sums.ac.ir) How to obtain: the request should be sent by email (containing personal and professional information), describing their study protocol, after approving their identity and proposal, the data will be sent by email. Comments:
public Dr. Reza Kaboodkhani
khalili street
Shiraz Iran (Islamic Republic of) 7193636981 +98 71 3629 1470 kaboodkhani@yahoo.com Shiraz University of Medical Sciences scientific Dr. Reza Kaboodkhani
khalili street
Shiraz Iran (Islamic Republic of) 7193636981 +98 71 3629 1470 kaboodkhani@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) ASA I physical status based on the American Classification of Anesthesiology (ASA) Age between 17 and 50 years Performing primary rhinoplasty with standard technique and oblique lateral-medial osteotomy 17 years 50 years Both Not agreeing to participate in the study Patients with cardiovascular disease History of sensitivity to bupivacaine Receiving other anesthetics before and during the operation Cognitive disorders and the inability to communicate and express the level of pain Z42 Encounter for plastic and reconstructive surgery following medical procedure or healed injury Prevention Prevention Prevention Other patients who at the end of the operation (before the patient regains consciousness) will be injected with bupivacaine (Marcaine® 0.5%: Aspen Japan; Tokyo, Japan) with a total volume of 4 ml as a local anesthetic. Intervention group:There are patients who will be administered local anesthetic bupivacaine (Marcaine® 0.5%: Aspen Japan; Tokyo, Japan) with a total volume of 4 ml at the beginning of the procedure. Intervention group: There are patients who receive local bupivacaine through the mesh (each mesh 1 cc, 2 cc in total) at the beginning of the procedure and bupivacaine injection (0.5 cc in each point, 2 cc in total) at the end of the procedure (a total of 4 cc of bupivacaine). Control group: No local anesthesia will be used Degree of nasal pain. Timepoint: 1 hour after the operation, 6 hours after the operation, 1 day after the operation, 2 days after the operation and 3 days after the operation. Method of measurement: Visual analog scale (VAS). Analgesic consumption. Timepoint: 1 hour after the operation, 6 hours after the operation, 1 day after the operation, 2 days after the operation and 3 days after the operation. Method of measurement: Asking the patient directly and recording analgesic consumption. Nausea-vomiting. Timepoint: 1 hour after the operation, 6 hours after the operation, 1 day after the operation, 2 days after the operation and 3 days after the operation. Method of measurement: Visual analog scale. Postoperative complications. Timepoint: up to 7 days. Method of measurement: direct physical examination. Shiraz University of Medical Sciences Approved 2024-01-16 Shiraz University of Medical Sciences Shiraz University of Medical Sciences - Zand street Shiraz Fars Iran (Islamic Republic of)