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

NCT06604598 | Completed Phase 4 DMC

• 1 other identifier: BUPARDEX
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Percutaneous Nephrolithotomy (PCNL); Postoperative Pain

Keywords

steroid; PGE2; analgesia; percutaneous nephrolithotomy; NSAID; postoperative pain

Outcome Measures

Primary Outcomes (2)

• NRS Score

  NRS score will be measured an hour after two times drug administration. The value scale from 0 to 10. Higher scores mean outcome worse.

  from enrollment to the end of treatment at 5 weeks

• PGE2 level

  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)

  from enrollment to the end of treatment at 5 weeks

Secondary Outcomes (1)

• The side effects

  from enrollment to the end of treatment at 5 weeks

Study Arms (3)

PCT-placebo-placebo

ACTIVE COMPARATOR

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.

Drug: PCT-placebo-placebo

IBU-PCT-placebo

ACTIVE COMPARATOR

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.

Drug: IBU-PCT-placebo

IBU-PCT-DEX

EXPERIMENTAL

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.

Drug: IBU-PCT-DEX

Interventions

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.

Also known as: Ibuprofen+paracetamol+dexamethasone

IBU-PCT-DEX

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

Also known as: ibuprofen+paracetamol+placebo

IBU-PCT-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.

PCT-placebo-placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Jenderal Soedirman: lead

Study Sites (1)

Margono Soekarjo Hospital

Banyumas, Central Java, 53146, Indonesia

Location

Related Publications (1)

• 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.

  PMID: 34961782 BACKGROUND

Related Links

• study protocol

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• M. Mukhlis Rudi Prihatno

  Universitas Jenderal Soedirman

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Department Anesthesiology and Intensive Therapy

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: October 8, 2024
• Primary Completion: November 8, 2024
• Study Completion: November 8, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)