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Completed

NCT Number: NCT05685342

Preemptive and Preventive Acetaminophen/Ibuprofen Fixed-dose Combination After Robot-assisted Radical Prostatectomy

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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Key information

Age range

19 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, KS013, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled to undergo elective robot-assisted radical prostatectomy under general anesthesia
  • American Society of Anesthesiologists (ASA) physical classification I-II
  • Consent to IV-patient controlled analgesia use
  • Willingness and ability to sign an informed consent document

Exclusion criteria

  • Who do not understand or agree with our study
  • American Society of Anesthesiologists (ASA) physical classification III-IV
  • Chronic usage of opioid analgesics
  • Moderate to severe pain with other cause before surgery
  • Allergies to anesthetic or analgesic medications used in this study
  • Anticipated blood loss larger than 2 liters
  • Need for intensive care after surgery
  • History of gastric ulcer or gastrointestinal bleeding
  • History of liver failure, renal failure or heart failure
  • Current alcoholism
  • Taking anti-coagulation drugs or history of coagulation disease
  • History of bronchial asthma
  • Medical or psychological disease that can affect the treatment response
  • Taking barbitutate or tricyclic antidepressant

Treatment and study plan

Acetaminophen/Ibuprofen fixed-dose combination

Drug

Intravenous administration of Acetaminophen (1000 mg)/Ibuprofen (300 mg) fixed-dose combination (total 100 ml)

Other names: Maxigesic

Primary outcomes

  1. Total fentanyl consumption during 24 hours

    Time frame: Postoperative 24 hours

    Postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

Secondary outcomes

  1. Total fentanyl consumption

    Time frame: Postoperative 2, 6, 48 hours

    Postoperative fentanyl consumption (mcg) via IV patient controlled analgesia (PCA)

  2. Postoperative pain score

    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"

  3. Count of rescue analgesics administration

    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

  4. Opioid side effects

    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 (%)

  5. Quality of recovery-15

    Time frame: Postoperative 24 hours

    Korean version of Quality of recovery-15 questionnaire (0-150): 0, "very poor recovery"; 150, "excellent recovery"

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Kyongbo Pharmaceutical

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2023
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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