The Effect of NSAID Steroid Therapy for PGE2 Level and Analgesia After Percutaneous Nephrolithotomy Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-08

Study Completion Date

2024-11-08

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Percutaneous Nephrolithotomy (PCNL) Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PCT-placebo-placebo

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.

Group Type ACTIVE_COMPARATOR

PCT-placebo-placebo

Intervention Type DRUG

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.

IBU-PCT-placebo

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 Type ACTIVE_COMPARATOR

IBU-PCT-placebo

Intervention Type DRUG

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

IBU-PCT-DEX

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 Type EXPERIMENTAL

IBU-PCT-DEX

Intervention Type DRUG

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.

Interventions

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IBU-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.

Intervention Type DRUG

IBU-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

Intervention Type DRUG

PCT-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.

Intervention Type DRUG

Other Intervention Names

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Ibuprofen+paracetamol+dexamethasone ibuprofen+paracetamol+placebo

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No