Investigating the effect of a single dose of dexamethasone on pain and ureteral obstruction after transurethral lithotripsy (TUL) operation in patients with unilateral ureteral stones

Investigating changes in pain and ureteral obstruction after transurethral lithotripsy (TUL) in patients with unilateral ureteral stones after receiving a single dose of dexamethasone

This study is a controlled, randomized, double-blind randomized clinical trial of phase 3 on 32 patients, which was used for randomization using seald-enevlop online software.

After visiting the Imam and Golestan hospitals, the patients will be selected and randomly assigned to two groups, and after obtaining permission from the Ethics Committee of Jundishapur University of Medical Sciences in Ahvaz and completing the informed consent form, the patients will be included in the study based on the desired criteria. will be studied.This study is a double-blind randomized controlled clinical trial.

Inclusion criteria: male and female patients with unilateral ureteral stones with normal creatinine, no leukocytosis and infectious symptoms, mild to moderate hydronephrosis in ultrasound and no other stones in any part of the urinary system. Exclusion criteria: patients with stones in other parts of the system. Urinary (except for non-obstructive calices stones), impacted stones (an obstructing ureteral stone that, during ureteroscopy, instead of passing through the stone, buckles around itself and creates buckling and does not pass through the stone through the stent, it is known and confirmed, Seizure history, patients with a history of alcohol and drug abuse, heart failure, fungal or viral systemic infection

One group of patients receives a single dose of 0.1 mg/kg (up to 8 mg/kg) dexamethasone half an hour before the operation, the other group receives two ml of injectable distilled water as a placebo.

Intensity of pain؛ Nausea؛ Vomit

Randomization in this study will be done by the block method, using the web-based random block system on the site www.sealdenevlop.com in six blocks of four. After the random sequence is determined in all blocks, cards with B, A written on them (group A of patients receiving dexamethasone and group B of patients receiving placebo) are prepared and numbered by another person other than the research team in the order of all blocks. And these cards are placed in sealed non-transparent envelopes. Then, in order to hide the random allocation, when the patient visits, the sealed opaque envelope will be opened and then it will be determined one by one for each patient of the relevant group.Finally, patients are divided into two groups of 16 for evaluation

Half an hour before the start of the surgery, two syringes covered by an opaque plastic sheath containing dexamethasone or distilled water as a placebo were given to the project researcher by the independent researcher present in the operating room, and randomly one of the syringes was given for injection based on a random table. It is selected from the serum attached to the patient's angiocyte. With this method, the researcher implementing the plan and the patient are unaware of the contents of the drug injected into the patient, and only the independent researcher knows about the contents of the drug injected into the patient. In this plan, patients are divided into two groups. One group of patients receives a single dose of dexamethasone half an hour before the operation, and the other group receives two milliliters of injectable distilled water as a placebo. For randomization, online software seald-enevlop (https://www.sealedenvelope.com/simple-randomiser/v1/lists) is used.