BUPARDEXNSAID Steroid Therapy for Pain Relief After Kidney Stone Surgery
IBU-PCT-DEX
+ IBU-PCT-placebo
+ PCT-placebo-placebo
Agnosia+8
+ Nervous System Diseases
+ Neurologic Manifestations
Treatment Study
Summary
Study start date: October 8, 2024
Actual date on which the first participant was enrolled.This study is exploring how a combination of medications can help control pain and inflammation after a kidney stone removal surgery called percutaneous nephrolithotomy. By focusing on patients who undergo this procedure, researchers aim to find out if using NSAID steroid therapy affects the levels of a substance called PGE2, which is linked to inflammation, as well as how effective the therapy is at managing pain. This is important because controlling pain and inflammation effectively can improve recovery and comfort for patients after surgery. Participants in this study are divided into three groups, each receiving a different set of medications through an intravenous (IV) route. One group receives ibuprofen, paracetamol, and dexamethasone, another group receives ibuprofen, paracetamol, and a placebo, and the last group receives paracetamol with two placebos. These medications are given during surgery and eight hours after the first dose. The study measures the level of PGE2 in the blood and uses a numeric rating scale to assess pain relief. Additionally, any side effects from the medications are monitored to ensure safety. This approach helps determine the best method for managing pain and inflammation post-surgery.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.45 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorGroup III
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location