Percutaneous Nephrolithotomy (PCNL)Phase 4BUPARDEXNCT06604598
The Effect of NSAID Steroid Therapy for PGE2 Level and Analgesia After Percutaneous Nephrolithotomy Surgery
A Phase 4 study testing IBU-PCT-DEX in people with Percutaneous Nephrolithotomy (PCNL) and Postoperative Pain, run by Universitas Jenderal Soedirman at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Percutaneous Nephrolithotomy (PCNL), Postoperative Pain
- What is being tested?
- IBU-PCT-DEX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteIndonesia
- Study dates
- 8 Oct 2024to 8 Nov 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
Participants will:
Receive drug intravenously according to group allocation, every 8 hours Report the side effects when taking medication during trial
Read the 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.
- Being tested
- IBU-PCT-DEX, IBU-PCT-placebo, PCT-placebo-placebo
- Keywords
- steroid, PGE2, analgesia, percutaneous nephrolithotomy, NSAID, postoperative pain
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBU-PCT-DEXDrug
Also called Ibuprofen+paracetamol+dexamethasone
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.
IBU-PCT-placeboDrug
Also called ibuprofen+paracetamol+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
PCT-placebo-placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: IBU-PCT-DEX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: from enrollment to the end of treatment at 5 weeks
Secondary outcomes (1)
The side effects
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.
Measured: from enrollment to the end of treatment at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start8 Oct 2024
- Primary completion8 Nov 2024
- Study completion8 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Nephrolithotomy (PCNL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Jenderal Soedirman
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erni Noviani, Universitas Jenderal Soedirman
- Investigators
- M. Mukhlis Rudi Prihatno, Study director, Universitas Jenderal Soedirman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604598
- Sponsor's protocol ID
- BUPARDEX
- Acronym
- BUPARDEX
- Status last verified
- Nov 2024
- First submitted
- 9 Sep 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is privacy according to our ethical research committee
Publications
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.
PubMed 34961782
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of NSAID Steroid Therapy for PGE2 Level and Analgesia After Percutaneous Nephrolithotomy Surgery, a Double Blinded Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06604598
- Acronym / sponsor ID
- BUPARDEX / BUPARDEX
- Keywords
- steroid, PGE2, analgesia, percutaneous nephrolithotomy, NSAID, postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universitas Jenderal SoedirmanUniversity, hospital or other
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| PCT-placebo-placebo | Active comparator | Drug: PCT-placebo-placeboParacetamol (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. |
| IBU-PCT-placebo | Active comparator | Drug: IBU-PCT-placeboIbuprofen (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. |
| IBU-PCT-DEX | Experimental | Drug: IBU-PCT-DEXIbuprofen (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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBU-PCT-DEXAlso: Ibuprofen+paracetamol+dexamethasoneIbuprofen (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. | Drug | IBU-PCT-DEX |
| IBU-PCT-placeboAlso: ibuprofen+paracetamol+placeboIbuprofen (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 | Drug | IBU-PCT-placebo |
| PCT-placebo-placeboParacetamol (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. | Drug | PCT-placebo-placebo |
Primary outcome
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.
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)
1 secondary outcome
The side effects
Time frame: from enrollment to the end of treatment at 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Background: PubMed 34961782Momesso 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.
- study protocolLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD is privacy according to our ethical research committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Mukhlis Rudi Prihatno study director
Universitas Jenderal Soedirman
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IBU-PCT-DEX in people with Percutaneous Nephrolithotomy (PCNL) and Postoperative Pain, run by Universitas Jenderal Soedirman at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS Score (time frame: from enrollment to the end of treatment at 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06604598, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.