Opioid-sparing Effect of Intravenous Ibuprofen

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03016650

Enrollment

Registered

2017-01-10

Start date

2017-01-31

Completion date

2017-05-31

Last updated

2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Percutaneous Nephrolithotomy

Keywords

Acetaminophen, Ibuprofen

Brief summary

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.

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

* 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.

Design outcomes

Primary

Measure	Time frame
Morphine Consumption	postoperatively 24 hours

Secondary

Measure	Time frame
Visual Analog Scale	postoperatively 30 minute, 2, 4, 6,12 and 24 hours

Contacts

Primary ContactMuharrem Ucar, Asst.Prof.

umuharrem@hotmail.com+90 422 341 06 60

Backup ContactMehmet ALi ERDOGAN, Ass.Prof.

drmalierdogan@gmail.com+90 422 341 06 60

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026