Completed

BUPARDEXNSAID Steroid Therapy for Pain Relief After Kidney Stone Surgery

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What is being tested

IBU-PCT-DEX

+ IBU-PCT-placebo

+ PCT-placebo-placebo

Drug
Who is being recruted

Agnosia+8

+ Nervous System Diseases

+ Neurologic Manifestations

From 18 to 70 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: October 2024
See protocol details

Summary

Principal SponsorUniversitas Jenderal Soedirman
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleThe Effect of NSAID Steroid Therapy for PGE2 Level and Analgesia After Percutaneous Nephrolithotomy Surgery, a Double Blinded Randomised Controlled Trial
NCT06604598
Principal SponsorUniversitas Jenderal Soedirman
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

AgnosiaNervous System DiseasesNeurologic ManifestationsPainPain, PostoperativePathologic ProcessesPerceptual DisordersPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral Manifestations

Criteria

5 inclusion criteria required to participate
Elective, percutaneous nephrolithotomy surgery

Age ≥ 18 years to ≤ 70 years

Body mass index (BMI) > 18 kg/m2 to < 40 kg/m2

American Society of Anesthesiologists (ASA) Physical Status Classification System 1-3.

Show More Criteria

10 exclusion criteria prevent from participating
Patients with allergy to ibuprofen, paracetamol, and dexamethasone

Patients with uncontrolled diabetes mellitus

Patients with previous history of alcohol or drug abuse

Patients who unconscious

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Ibuprofen (Peinlos) 400 mg iv, Paracetamol (Bernofarm) 1 gr iv, dexamethasone (Phapros) 5 mg iv will be given two times administration, interval 8 hour, within IBU-PCT-DEX intervention.

Group II

Active Comparator
Ibuprofen (Peinlos) 400 mg iv; Paracetamol (Bernofarm) 1 gr iv; and placebo (normal saline alike dexamethasone) will be given two times administration, interval 8 hour, within the IBU-PCT-placebo intervention.

Group III

Active Comparator
Paracetamol (Bernofarm) 1 gr iv; placebo (normal saline alike paracetamol); placebo (normal saline alike dexamethasone) will be given two times administration, interval 8 hour, within the PCT-placebo intervention.

Study 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

Suspended

Margono Soekarjo Hospital

Banyumas, IndonesiaOpen Margono Soekarjo Hospital in Google Maps
CompletedOne Study Center