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IRCT20210509051237N1 IRCT 2023-09-27 Birjand University of Medical Sciences Effect of Dexamethasone injection on trans ureteral lithotripsy postoperative pain The efficacy of intra-pyelocaliceal injection of dexamethasone in trans ureteral lithotripsy on postoperative analgesics consumption: A triple-blinded randomized clinical trial 2023-11-22 anticipated 80 Complete https://irct.ir/trial/70646 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In addition to the centralized computer randomization system, the method of simple randomization was used to allocate patients to either the control or intervention group. The randomization unit for this study was patients who met the eligibility criteria. No cluster randomization was used in this trial. To create a random sequence for the study, the study team used a random number generator built into the REDCap Cloud system. To maintain allocation concealment, the allocation sequence was kept hidden from the study team until the point of randomization. This was achieved through the use of a centralized automated system, which prevented study personnel from predicting the allocation sequence or knowing the allocation of any individual patient before randomization, Blinding description: In addition to randomization and allocation concealment, this study also utilized a triple-blinding process. To achieve participant blinding, both the intervention and control groups received an identical-appearing treatment, they underwent the same type of surgery, and stents were implanted for both groups; However, all patients were aware that they were participating in a study and received the main treatment. Study personnel were also blinded to the treatment allocation. The healthcare providers, researchers, and study coordinators involved in any aspect of the study conduct were unaware of the treatment assignments. Lastly, outcome assessors were blinded by having a separate team of blinded assessors who were not involved in patient care and who performed the outcome assessments. Only the urologist and anesthesiologist were aware of each patient's group. 3 Condition 1: Calculus of ureter. Condition 2: Postoperative pain of uretroscopy. Intervention 1: Intervention group: the urologist surgeon injected one ampoule of dexamethasone (Alborzdarou) (8mg/2mL) into the pyelocaliceal space for patients in the intervention group using a 9.8 French semi-rigid ureteroscope and then placed a double-J 4.7 French stent at 28 cm (Goharshafa). Intervention 2: Control group: no dexamethasone or other drugs were injected into the pyelocaliceal space before placing the double-J stent. Yes - There is a plan to make this available What will be shared: All data after de-identifying individuals When: The access period starts 6 months after the results are published. To whom: Researchers in scientific and academic institutions Conditions: Analyzing the data is allowed if it is part of a larger study. Where to obtain: To receive data or documents, you can send your request via email to one of the following people: 1. Dr. Ramin Honarmand, the main researcher ramin_h_1360@yahoo.com 2. Hadis Enayati, a member of the research team hadissenayati@gmail.com How to obtain: The submitted request will be reviewed within a week and the data file and documents will be sent via email within a maximum of 2 weeks. Comments:
public Ramin Honarmand
No. 9, No 8/6 Alley, Taleghani 8 St, Taleghani Ave
Birjand Iran (Islamic Republic of) 9817713881 +98 56 3222 4710 raminhonarmand@bums.ac.ir Birjand University of Medical Sciences scientific Ramin Honarmand
No. 9, No 8/6 Alley, Taleghani 8 St, Taleghani Ave
Birjand Iran (Islamic Republic of) 9817713881 +98 56 3222 4710 raminhonarmand@bums.ac.ir Birjand University of Medical Sciences Iran (Islamic Republic of) Patients with ureteral stones (requiring TUL operation) Ages over 18 years written informed consent to participate in the study 18 years no limit Both N20.1 N99 Calculus of ureter Intraoperative and postprocedural complications and disorders of genitourinary system, not elsewhere classified Prevention Prevention Intervention group: the urologist surgeon injected one ampoule of dexamethasone (Alborzdarou) (8mg/2mL) into the pyelocaliceal space for patients in the intervention group using a 9.8 French semi-rigid ureteroscope and then placed a double-J 4.7 French stent at 28 cm (Goharshafa). Control group: no dexamethasone or other drugs were injected into the pyelocaliceal space before placing the double-J stent. Postoperative analgesics consumption. Timepoint: After recovery and transferring the patients to the ward until discharge. Method of measurement: The amount of analgesics received by the patient based on his needs, recorded by the nurses. Birjand University of Medical Sciences Approved 2021-04-19 Ethics committee of Birjand University of Medical Sciences Birjand University of Medical Sciences, Ghaffari Ave. Birjand South Khorasan Iran (Islamic Republic of)