The efficacy of intra-pyelocaliceal injection of dexamethasone in trans ureteral lithotripsy on postoperative analgesics consumption: A triple-blinded randomized clinical trial

Investigation of the effect of dexamethasone administration in the pyelocaliceal space of the kidney in transurethral lithotripsy (TUL) on postoperative analgesic consumption.

Randomized, parallel-group trial with blinded outcome assessment, and data analysis. A centralized computer randomization system was used.

The urologist injected one ampoule of dexamethasone into the pyelocaliceal space for patients in the intervention group using a ureteroscope before double J stent placement. In the control group, no drug was injected into the pyelocaliceal space. After recovery and transferring the patients to the ward, based on the patient's needs and the pain intensity stated by the patients, analgesics drug consumption was recorded. Follow-up of patients continued until discharge from the hospital. All patients, outcome assessors, and caregivers were blinded to the intervention group. The study was conducted in the urology department and operating room of Razi Medical Education Hospital in Birjand city, South Khorasan province, Iran.

Inclusion criteria included patients with ureteral stones (requiring TUL operation), ages over 18 years, and written consent to participate in the study. Exclusion criteria included pregnancy, single kidney, urinary tract infection, drug or psychotropic addiction, ureteral rupture, use of ureteroscope and stents of different sizes, and history of sensitivity to dexamethasone.

The urologist surgeon injected one ampoule of dexamethasone (8mg/2mL) into the pyelocaliceal space for patients in the intervention group using a ureteroscope and then placed a double J. In the control group, no dexamethasone ampoule or other drugs were injected into the pyelocaliceal space before placing the double J stent.

Postoperative analgesics consumption

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.

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.

All data after de-identifying individuals

The access period starts 6 months after the results are published.

Researchers in scientific and academic institutions

Analyzing the data is allowed if it is part of a larger study.

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

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.