Percutaneous Nephrolithotomy (PCNL), Postoperative Pain
Conditions
Keywords
steroid, PGE2, analgesia, percutaneous nephrolithotomy, NSAID, postoperative pain
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 side effects of combination of those drugs. The main questions it aims to answer are: Does combination of NSAID steroid can lower the PGE2 level and NRS score after percutaneous nephrolithotomy surgery? What side effect do participants have when taking combination of NSAID-steroid after percutaneous nephrolithotomy surgery? Researchers will compare Group IBU-PCT-DEX (ibuprofen -paracetamol-dexamethasone), Group IBU-PCT-placebo (ibuprofen-paracetamol-placebo), and Group PCT-placebo-placebo (paracetamol-placebo-placebo) to see the difference level of PGE2 and NRS score after percutaneous nephrolithotomy surgery. Participants will: Receive drug intravenously according to group allocation, every 8 hours Report the side effects when taking medication during trial
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 primary health care center in Purwokerto, Indonesia. This trial involved 45 patient who underwent elective percutaneous nephrolithotomy surgery who met the inclusion and exclusion criteria. Patient was randomized and divided into three groups. Each group consisted of 15 patients. Ibuprofen 2x400 mg iv + paracetamol 2x1 gr iv + dexamethasone 2x5 mg iv will be given within the IBU-PCT-DEX intervention. Ibuprofen 2x400 mg iv + paracetamol 2x1gr iv + 2xplacebo (normal saline alike dexamethasone) iv will be given within the IBU-PCT-placebo intervention. Paracetamol 2x1 gr iv + 2xplacebo (normal saline alike ibuprofen) + 2xplacebo (normal saline alike dexamethasone) will be given within the PCT-placebo-placebo intervention. The analgesics were given during surgery and 8 hours after first drug administration. Plasma level of PGE2 will be measured with ELISA. and analgesia will be measured using numeric rating scale (NRS) an hour after two times drug administration. Primary outcome was PGE2 level and NRS score after percutaneous nephrolithotomy among three group of comparison. Secondary outcome was the side effect of analgesic.
Interventions
DRUGIBU-PCT-DEX
Ibuprofen (Peinlos) 2x400 mg iv, Paracetamol (Bernofarm) 2x1 gr iv, dexamethasone (Phapros) 2x5 mg iv will be given with interval 8 hour, within the IBU-PCT-DEX intervention.
DRUGIBU-PCT-placebo
Ibuprofen (Peinlos) 2x400 mg iv, Paracetamol (Bernofarm) 2x1 gr iv, and 2xplacebo (normal saline alike dexamethasone) will be given with interval 8 hour, within the IBU-PCT-placebo intervention
DRUGPCT-placebo-placebo
Paracetamol (Bernofarm) 2x1 gr iv, 2xplacebo (normal saline alike paracetamol), 2xplacebo (normal saline alike dexamethasone) will be given with interval 8 hour, within the PCT-placebo-placebo intervention.
Sponsors
Universitas Jenderal Soedirman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
BUPARDEX (iBUprofen, PARacetamol, DEXamethasone) is a parallel 3-group, blinded, randomized controlled trial. Participants were randomized using random generator application, and divided to 3 groups in a 1:1:1 ratio. Ibuprofen (Peinlos) 400 mg iv, Paracetamol (Bernofarm) 1 gr iv, dexamethasone (Phapros) 5 mg iv will give within IBU-PCT-DEX intervention. Ibuprofen (Peinlos) 400 mg iv; Paracetamol (Bernofarm) 1 gr iv; and placebo (normal saline alike dexamethasone) will give within the IBU-PCT-placebo intervention. Paracetamol (Bernofarm) 1 gr iv; placebo (normal saline alike paracetamol); placebo (normal saline alike dexamethasone) will give within PCT-placebo-placebo intervention. All drugs manufactured by Indonesia. The study was conducted after obtaining an ethical clearance from the Medical Research Ethics Commission, Faculty of Medicine, Universitas Jenderal Soedirman (No. 052/KEPK/PE/VII/2024). Participant, care provider, investigator, outcome assessor will be blind during trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Elective, percutaneous nephrolithotomy surgery 2. Age ≥ 18 years to ≤ 70 years 3. Body mass index (BMI) > 18 kg/m2 to < 40 kg/m2 4. American Society of Anesthesiologists (ASA) Physical Status Classification System 1-3. 5. Written informed consent to participate in the trial.
Exclusion criteria
1. Patients with allergy to ibuprofen, paracetamol, and dexamethasone 2. Patients with uncontrolled diabetes mellitus 3. Patients with previous history of alcohol or drug abuse 4. Patients who unconscious 5. Patients with neurological disorders 6. Patients with cognitive impairment 7. Patients who incapable of communication 8. Patients with daily use of systemic glucocorticoids within 3 months prior to surgery 9. Patients with daily use of high-dose opioid (tramadol 150 mg/day or morphine >30 mg/day orally) or use transdermal opioid 10. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS Score | from enrollment to the end of treatment at 5 weeks | NRS score will be measured an hour after two times drug administration. The value scale from 0 to 10. Higher scores mean outcome worse. |
| PGE2 level | from enrollment to the end of treatment at 5 weeks | PGE2 level will be measured by ELISA elabscience kit. PGE2 level will be measured an hour after two times drug administration, using plasma sample. The result is displayed in pg/ml (numeric scale) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The side effects | from enrollment to the end of treatment at 5 weeks | The side effects of trial medication to participants including nausea, vomiting, epigastric pain, allergy, and no side effect. Data will be collected after two times drug administration. |
Countries
Indonesia
Outcome results
None listed