]>
IRCT20230416057931N1 IRCT 2023-10-02 Tehran University of Medical Sciences The role of Serratus anterior plane block to manage post-thoracotomy pain: a randomized controlled trial, Phase II Evaluating the role of Serratus anterior plane block to manage post-thoracotomy pain: a randomized controlled trial, Phase II 2023-07-18 anticipated 120 Complete https://irct.ir/trial/70771 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study randomization performs based on the blocked randomization method. Information such as the number of study groups (2 main groups: intervention (for example A) and control (for example (B), block size (a multiple of the number of groups that will be chosen in this study to reduce the complexity of the work, size 4) and the total number of patients (sample size 60 people), were enter into the online software machines specific for this calculation (for example available at https://www.sealedenvelope.com/simple-randomiser/v1/lists) and according to the codes that it is obtained by the final analysis (including the number of specific groups of 4, which will be 17 groups here) (for example (group B 1, 4, 1, each of the patients being studied is given a specific code respectively. Blocking is usually used in order to create a balance in the number of samples assigned to each of the studied groups. In this method, equal blocking will be used. In this way, the samples are randomized in two groups as much as possible, Blinding description: All steps of group assignment are done by a researcher who does not have a role in the data collection, and the data will be recorded by a researcher who is blind to the group allocation and was not involved or present during the surgery, and will not know about the sample group until after the data analysis. Patients do not know which group they are in and the intervention is done before the patient regains consciousness. 2 Serratus anterior plane block. Intervention group:. 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 aren't more information
public Yaser Ftouni
Felestin St., Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1416634793 +98 21 8895 1390 Yaser.ftouni91@gmail.com Tehran University of Medical Sciences scientific Yaser Ftouni
Felestin St., Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8895 1390 Yaser.ftouni91@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with American Society of Anesthesiologists class (ASA) class I–II criteria 18 years no limit Both Participants who refused to cooperate History hypersensitivity to local anesthesia Patients with American Society of Anesthesiologists class (ASA) class IV-V criteria Unstable hemodynamic (systolic blood pressure <90 mm-Hg or mean arterial pressure< 60 mm-Hg) Coagulation disorders Surgery site infection Treatment - Other Intervention group: Post-thoracotomy pain. Timepoint: Pain severity score 6, 12 and 24 hours after surgery. Method of measurement: Visual analog scale for pain (VAS). Tehran University of Medical Sciences Approved 2023-06-15 Ethic Committee of Tehran University of Medical Sciences Keshavarz Blvd., Qods St., Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)