Clinical trial NCT06604598: The Effect of NSAID Steroid Therapy for PGE2 Level and Analgesia After Percutaneous Nephrolithotomy Surgery
Official title: The Effect of NSAID Steroid Therapy for PGE2 Level and Analgesia After Percutaneous Nephrolithotomy Surgery, a Double Blinded Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Percutaneous Nephrolithotomy (PCNL)
Postoperative Pain
Keywords: steroid
PGE2
analgesia
percutaneous nephrolithotomy
NSAID
postoperative pain
Lead sponsor: Universitas Jenderal Soedirman
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Elective, percutaneous nephrolithotomy surgery
2. Age ≥ 18 years to ≤ 70 years
3. Body mass index (BMI) \&gt; 18 kg/m2 to \&lt; 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 \&gt;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 \&lt;60 ml/kg/1.73 m2), heart failure, severe liver dysfunction, thrombocytopenia \&lt;100,000/L.

Primary outcomes:
measure: NRS Score
timeFrame: from enrollment to the end of treatment at 5 weeks
measure: PGE2 level
timeFrame: from enrollment to the end of treatment at 5 weeks
Secondary outcomes:
measure: The side effects
timeFrame: from enrollment to the end of treatment at 5 weeks
Other outcomes:
Locations:
city: Banyumas
country: Indonesia
facility: Margono Soekarjo Hospital
state: Jawa Tengah
Study officials:
affiliation: Universitas Jenderal Soedirman
name: M. Mukhlis Rudi Prihatno
role: STUDY_DIRECTOR
References:
citation: Momesso GAC, Grossi-Oliveira GA, Silva WPP, Akira R, Chiba F, Polo TOB, de Lima Neto TJ, Rios BR, Bassi APF, Sumida DH, Han M, Miloro M, Faverani LP. A triple-blind randomized clinical trial of different associations between dexamethasone and non-steroids anti-inflammatories for preemptive action in third molar extractions. Sci Rep. 2021 Dec 27;11(1):24445. doi: 10.1038/s41598-021-04068-z.