-
Study aim
-
The aim of this study was to provide an appropriate pharmacological solution to reduce patients 'anxiety before PCNL surgery and also to reduce patients' pain after PCNL surgery.
-
Design
-
A clinical trial with the control group, with parallel groups, double-blind, randomly sealed by envelope method, total sample size of 100 patients, phase 3 trial
-
Settings and conduct
-
This study will be performed in Shohada Tajrish Hospital in Tehran. Patients who are candidates for PCNL surgery due to kidney stones are randomly divided into 4 groups and will receive 75 mg pregabalin, 150 mg pregabalin, 300 mg pregabalin, and placebo, respectively, 2 hours before surgery. For all patients, the level of anxiety will be measured and compared using the Hamilton Questionnaire (HAM-A) before and 1.5 hours after medication. After surgery, patients' pain will be measured and compared based on the VAS questionnaire, at 2, 6, 12, and 24 hours after surgery. It is two-way blind and the questioner and the patient will not know how to divide patients into the mentioned groups.
-
Participants/Inclusion and exclusion criteria
-
Participants in this study are patients who are candidates for PCNL surgery due to kidney stones. Inclusion criteria include: 18 to 60 years old and ASA score one or two. Exclusion criteria include taking drugs that interact with pregabalin, including (rosiglitazone - pioglitazone - benzodiazepines - ACEIs) ؛ people who use alcohol؛ a history of psychiatric disorders including suicidal ideation and depression؛ history of heart failure Has؛ history of kidney failure and pregnant or lactating women.
-
Intervention groups
-
Patients are divided into 4 groups. 2 hours before surgery, the first group will receive 75 mg pregabalin, the second group 150 mg pregabalin, the third group 300 mg pregabalin, and the fourth group placebo.
-
Main outcome variables
-
Reduce pre-operative anxiety; Reduce postoperative pain