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Status unknownNCT03016650Updated Jan 18, 2017

Opioid-sparing Effect of Intravenous Ibuprofen

A Phase 4 interventional study of Acetaminophen and Ibuprofen in Analgesia and Percutaneous Nephrolithotomy, sponsored by Muharrem Ucar. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-01-18.

Sponsored by Muharrem Ucar · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Analgesia
  • Percutaneous Nephrolithotomy

Keywords

  • Acetaminophen
  • Ibuprofen
03

In context

Lead sponsor

This is the only study on the registry with Muharrem Ucar as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    Paracetamol

    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.

    Drug: Acetaminophen

  • Active comparator
    ibuprofen

    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.

    Drug: Ibuprofen

Interventions

  • DrugAcetaminophen

    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

    Also known as: Perfalgan

  • DrugIbuprofen

    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

    Also known as: Intrafen

06

What researchers measure

Primary outcomes

  1. Morphine Consumption

    Time frame: postoperatively 24 hours

Secondary outcomes

  1. Visual Analog Scale

    Time frame: postoperatively 30 minute, 2, 4, 6,12 and 24 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03016650
Lead sponsor
Muharrem Ucar
Responsible party
Muharrem Ucar (Principal Investigator, Inonu University) — Sponsor-investigator
First posted
Jan 10, 2017
Start date
Jan 2017
Primary completion
Apr 2017 (estimated)
Completion
May 2017 (estimated)
Last update
Jan 18, 2017

Study contacts

Muharrem Ucar, Asst.Prof.
Contact
umuharrem@hotmail.com
+90 422 341 06 60 ext. 3136
Mehmet ALi ERDOGAN, Ass.Prof.
Contact
drmalierdogan@gmail.com
+90 422 341 06 60 ext. 6419
Muharrem Ucar
principal investigator · İnonu University Faculty of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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