Seoul National University Hospital
Seoul, KS013, South Korea
NCT Number: NCT05685342
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.
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Notify Me19 year–80 year
Male
Interventional
Not applicable
Seoul, KS013, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous administration of Acetaminophen (1000 mg)/Ibuprofen (300 mg) fixed-dose combination (total 100 ml)
Other names: Maxigesic
Time frame: Postoperative 24 hours
Postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
Time frame: Postoperative 2, 6, 48 hours
Postoperative fentanyl consumption (mcg) via IV patient controlled analgesia (PCA)
Time frame: Postoperative 2 (resting only), 6, 24, 48 hours
11-pointed NRS pain score at resting/coughing NRS (0-10): 0,"no pain"; 10, "worst pain imaginable"
Time frame: Postoperative 0-2, 2-6, 6-24, 24-48 hours
Number of count of rescue analgesics administered because of patient's request for additional analgesia than IV PCA
Time frame: Postoperative 0-2, 2-6, 6-24, 24-48 hours
Incidence of opioid side effects like postoperative nausea/vomiting, hypotension, dizziness, somnolence and respiratory depression (%)
Time frame: Postoperative 24 hours
Korean version of Quality of recovery-15 questionnaire (0-150): 0, "very poor recovery"; 150, "excellent recovery"
Seoul National University Hospital
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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