Trials / Completed
CompletedNCT05685342
Preemptive and Preventive Acetaminophen/Ibuprofen Fixed-dose Combination After Robot-assisted Radical Prostatectomy
Comparison of the Opioid-sparing Effect of Preemptive and Preventive Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination After Robot-assisted Radical Prostatectomy: A Double-blind Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 154 (actual)
- Sponsor
- Seoul National University Hospital · Academic / Other
- Sex
- Male
- Age
- 19 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This prospective, randomized, double-blinded study is designed to compare opioid-sparing effect of preemptive and preventive intravenous acetaminophen/ibuprofen fixed-dose combination in patients undergoing robot-assisted radical prostatectomy (RARP). We hypothesize that preemptive administration of intravenous acetaminophen/ibuprofen fixed-dose combination can significantly reduce postoperative opioid consumption and pain severity than preventive administration in patients undergoing RARP.
Detailed description
Adult patients undergoing elective robot-assisted radical prostatectomy are randomly allocated to receive preemptive administration of acetaminophen (1000 mg)/ibuprofen (300 mg) fixed-dose combination (n=77) or preventive administration (n=77). The preemptive administration group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 minutes at the end of induction of anesthesia. The preventive administration group will receive same dosage of drug for same duration when surgical site closure starts.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Acetaminophen/Ibuprofen fixed-dose combination | Intravenous administration of Acetaminophen (1000 mg)/Ibuprofen (300 mg) fixed-dose combination (total 100 ml) |
Timeline
- Start date
- 2023-02-10
- Primary completion
- 2025-02-28
- Completion
- 2025-07-30
- First posted
- 2023-01-17
- Last updated
- 2025-09-11
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05685342. Inclusion in this directory is not an endorsement.