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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Acetaminophen/Ibuprofen fixed-dose combination

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.

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul
    • Seoul, Seoul, South Korea, KS013
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preemptive administration group; Preemptive administration group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 minutes at the end of induction of anesthesia.	Drug: Acetaminophen/Ibuprofen fixed-dose combination; Intravenous administration of Acetaminophen (1000 mg)/Ibuprofen (300 mg) fixed-dose combination (total 100 ml); Other Names: Maxigesic
Active Comparator: Preventive administration group; The preventive administration group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 minutes when surgical site closure starts.	Drug: Acetaminophen/Ibuprofen fixed-dose combination; Intravenous administration of Acetaminophen (1000 mg)/Ibuprofen (300 mg) fixed-dose combination (total 100 ml); Other Names: Maxigesic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total fentanyl consumption during 24 hours	Postoperative fentanyl consumption (mcg) via IV patient controlled analgesia	Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total fentanyl consumption	Postoperative fentanyl consumption (mcg) via IV patient controlled analgesia (PCA)	Postoperative 2, 6, 48 hours
Postoperative pain score	11-pointed NRS pain score at resting/coughing NRS (0-10): 0,"no pain"; 10, "worst pain imaginable"	Postoperative 2 (resting only), 6, 24, 48 hours
Count of rescue analgesics administration	Number of count of rescue analgesics administered because of patient's request for additional analgesia than IV PCA	Postoperative 0-2, 2-6, 6-24, 24-48 hours
Opioid side effects	Incidence of opioid side effects like postoperative nausea/vomiting, hypotension, dizziness, somnolence and respiratory depression (%)	Postoperative 0-2, 2-6, 6-24, 24-48 hours
Quality of recovery-15	Korean version of Quality of recovery-15 questionnaire (0-150): 0, "very poor recovery"; 150, "excellent recovery"	Postoperative 24 hours

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Kyongbo Pharmaceutical
• Investigators: Principal Investigator: Hojin Lee, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2023
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Organic Chemicals; Carboxylic Acids; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Acids, Carbocyclic; Phenylpropionates; Acetaminophen; Ibuprofen
• Other Study ID Numbers: Maxigesic_Pre

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No