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

November 9, 2024 updated by: Erni Noviani, Universitas Jenderal Soedirman

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Jawa Tengah
      • Banyumas, Jawa Tengah, Indonesia, 53146
        • Margono Soekarjo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Active Comparator: 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.
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
Other Names:
  • ibuprofen+paracetamol+placebo
Experimental: 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.
Drug: 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.
Other Names:
  • Ibuprofen+paracetamol+dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from enrollment to the end of treatment at 5 weeks
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)
from enrollment to the end of treatment at 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from enrollment to the end of treatment at 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Jenderal Soedirman

Investigators

  • Study Director: M. Mukhlis Rudi Prihatno, Universitas Jenderal Soedirman

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2024

Primary Completion (Actual)

November 8, 2024

Study Completion (Actual)

November 8, 2024

Study Registration Dates

First Submitted

September 9, 2024

First Submitted That Met QC Criteria

September 17, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 12, 2024

Last Update Submitted That Met QC Criteria

November 9, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUPARDEX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD is privacy according to our ethical research committee

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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