AnalgesiaPhase 4NCT03016650
Opioid-sparing Effect of Intravenous Ibuprofen
A Phase 4 study testing Acetaminophen and Ibuprofen in people with Analgesia and Percutaneous Nephrolithotomy, run by Muharrem Ucar.
Trial summary
The investigators aimed to evaluate tramadol-sparing effect of intravenous (IV) ibuprofen in patients undergoing percutaneous nephrolithotomy (PCNL). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Analgesia, Percutaneous Nephrolithotomy
- What is being tested?
- Acetaminophen and Ibuprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to May 2017
- 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
- Study include 80 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-70 years who scheduled for percutaneous nephrolithotomy operation.
Who cannot join
- chronic pain,
- psychiatric disease,
- renal dysfunction,
- allergy to nonsteroidal anti-inflammatory drugs,
- history of drug addiction,
- pregnancy,
- inability to use a patient controlled analgesia (PCA) device.
Trial locations and contacts
No sites are listed yet.
About this study
The investigators aimed to evaluate tramadol-sparing effect of intravenous (IV) ibuprofen in patients undergoing percutaneous nephrolithotomy (PCNL).
Read the detailed description
Eighty patients who will undergoing PCNL are randomized to intravenous paracetamol (n=40) and intravenous ibuprofen (n=40) groups. Patients will receive 100 mL of physiologic saline with 1 g IV paracetamol or 800 mg IV ibuprofen 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after PCNL in the paracetamol and ibuprofen groups, respectively. Patients in both groups will receive intravenous tramadol with patient controlled analgesia device (PCA).
The visual analog scale (VAS) will used to evaluate pain intensity scores in the postoperative period.
Total tramadol consumption, mean VAS score in the 1, 8 and 24 hours, demographic variables, operative variables, and side effects will record.
- Conditions
- Analgesia, Percutaneous Nephrolithotomy
- Being tested
- Acetaminophen, Ibuprofen
- Keywords
- Acetaminophen, Ibuprofen
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Perfalgan
Patients receive 100 mL of physiologic saline with 1 g IV paracetamol 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after PCNL
IbuprofenDrug
Also called Intrafen
Patients receive 100 mL of physiologic saline with 800 mg IV ibuprofen 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after PCNL
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol | Active comparator | Patients will receive 100 mL of physiologic saline with 1 g IV acetaminophen (paracetamol) 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after percutaneous nephrolithotomy, respectively. Receives: Drug: Acetaminophen |
| ibuprofen | Active comparator | Patients will receive 100 mL of physiologic saline with 800 mg IV ibuprofen 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after percutaneous nephrolithotomy, respectively. Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Consumption
Measured: postoperatively 24 hours
Secondary outcomes (1)
Visual Analog Scale
Measured: postoperatively 30 minute, 2, 4, 6,12 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionApr 2017 (estimated)
- Study completionMay 2017 (estimated)
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 AnalgesiaStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muharrem Ucar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muharrem Ucar, Inonu University
- Investigators
- Muharrem Ucar, Principal investigator, İnonu University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016650
- Sponsor's protocol ID
- muharrem-1
- Status last verified
- Jan 2017
- First submitted
- 9 Jan 2017
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Maghsoudi R, Tabatabai M, Radfar MH, Movasagi G, Etemadian M, Shati M, Amjadi M. Opioid-sparing effect of intravenous paracetamol after percutaneous nephrolithotomy: a double-blind randomized controlled trial. J Endourol. 2014 Jan;28(1):23-7. doi: 10.1089/end.2013.0267. Epub 2013 Oct 17.
PubMed 23952097
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid-sparing Effect of Intravenous Ibuprofen
- ClinicalTrials.gov ID
- NCT03016650
- Acronym / sponsor ID
- muharrem-1
- Conditions
- Analgesia, Percutaneous Nephrolithotomy
- Keywords
- Acetaminophen, Ibuprofen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Muharrem UcarUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Apr 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 10 Jan 2017 (estimated)
- 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 investigators aimed to evaluate tramadol-sparing effect of intravenous (IV) ibuprofen in patients undergoing percutaneous nephrolithotomy (PCNL).
Detailed description
Eighty patients who will undergoing PCNL are randomized to intravenous paracetamol (n=40) and intravenous ibuprofen (n=40) groups. Patients will receive 100 mL of physiologic saline with 1 g IV paracetamol or 800 mg IV ibuprofen 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after PCNL in the paracetamol and ibuprofen groups, respectively. Patients in both groups will receive intravenous tramadol with patient controlled analgesia device (PCA).
The visual analog scale (VAS) will used to evaluate pain intensity scores in the postoperative period.
Total tramadol consumption, mean VAS score in the 1, 8 and 24 hours, demographic variables, operative variables, and side effects will record.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Active comparator | Drug: AcetaminophenPatients will receive 100 mL of physiologic saline with 1 g IV acetaminophen (paracetamol) 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after percutaneous nephrolithotomy, respectively. |
| ibuprofen | Active comparator | Drug: IbuprofenPatients will receive 100 mL of physiologic saline with 800 mg IV ibuprofen 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after percutaneous nephrolithotomy, respectively. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Study include 80 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-70 years who scheduled for percutaneous nephrolithotomy operation.
Key exclusion criteria (7 listed)
- chronic pain,
- psychiatric disease,
- renal dysfunction,
- allergy to nonsteroidal anti-inflammatory drugs,
- history of drug addiction,
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 |
|---|---|---|
| AcetaminophenAlso: PerfalganPatients receive 100 mL of physiologic saline with 1 g IV paracetamol 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after PCNL | Drug | Paracetamol |
| IbuprofenAlso: IntrafenPatients receive 100 mL of physiologic saline with 800 mg IV ibuprofen 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after PCNL | Drug | ibuprofen |
Primary outcome
Morphine Consumption
Time frame: postoperatively 24 hours
1 secondary outcome
Visual Analog Scale
Time frame: postoperatively 30 minute, 2, 4, 6,12 and 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Results publication: PubMed 23952097Maghsoudi R, Tabatabai M, Radfar MH, Movasagi G, Etemadian M, Shati M, Amjadi M. Opioid-sparing effect of intravenous paracetamol after percutaneous nephrolithotomy: a double-blind randomized controlled trial. J Endourol. 2014 Jan;28(1):23-7. doi: 10.1089/end.2013.0267. Epub 2013 Oct 17.
- Individual participant dataSharing planned: No
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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.
Muharrem Ucar principal investigator
İnonu University Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen and Ibuprofen in people with Analgesia and Percutaneous Nephrolithotomy, run by Muharrem Ucar.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muharrem Ucar, Asst.Prof. (+90 422 341 06 60 ext. 3136, umuharrem@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine Consumption (time frame: postoperatively 24 hours). 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 NCT03016650, 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 18 Jan 2017.