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Completed

NCT Number: NCT06604598

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

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Margono Soekarjo Hospital

Banyumas, Central Java, 53146, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

IBU-PCT-DEX

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.

Other names: Ibuprofen+paracetamol+dexamethasone

IBU-PCT-placebo

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

Other names: ibuprofen+paracetamol+placebo

PCT-placebo-placebo

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.

Primary outcomes

  1. NRS Score

    Time frame: 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.

  2. PGE2 level

    Time frame: 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 outcomes

  1. The side effects

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universitas Jenderal Soedirman

Other

Registry information

Official study title

The Effect of NSAID Steroid Therapy for PGE2 Level and Analgesia After Percutaneous Nephrolithotomy Surgery, a Double Blinded Randomised Controlled Trial

Acronym: BUPARDEX

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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