Status:
COMPLETED
The Effect of NSAID Steroid Therapy for PGE2 Level and Analgesia After Percutaneous Nephrolithotomy Surgery
Lead Sponsor:
Universitas Jenderal Soedirman
Conditions:
Percutaneous Nephrolithotomy (PCNL)
Postoperative Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to learn if combination of NSAID-steroid can decrease the PGE2 level and postoperative pain after percutaneous nephrolithotomy surgery. It will also learn about the ...
Detailed Description
Our study aim to investigate the effect of NSAID steroid therapy to PGE2 level and analgesia after percutaneous nephrolithotomy surgery. This study is a double blind randomized controlled trial at a p...
Eligibility Criteria
Inclusion
- 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.
- Written informed consent to participate in the trial.
Exclusion
- 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
- Patients with neurological disorders
- Patients with cognitive impairment
- Patients who incapable of communication
- Patients with daily use of systemic glucocorticoids within 3 months prior to surgery
- Patients with daily use of high-dose opioid (tramadol 150 mg/day or morphine \>30 mg/day orally) or use transdermal opioid
- Patients who are contraindicated to ibuprofen or paracetamol, include a history of peptic ulcers, renal failure (glomerular filtration rate \<60 ml/kg/1.73 m2), heart failure, severe liver dysfunction, thrombocytopenia \<100,000/L.
Key Trial Info
Start Date :
October 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06604598
Start Date
October 8 2024
End Date
November 8 2024
Last Update
November 12 2024
Active Locations (1)
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1
Margono Soekarjo Hospital
Banyumas, Central Java, Indonesia, 53146