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

NCT05685342 | Completed

• 1 other identifier: Maxigesic_Pre
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Keywords

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Total fentanyl consumption during 24 hours

  Postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

  Postoperative 24 hours

Secondary Outcomes (5)

• Total fentanyl consumption

  Postoperative 2, 6, 48 hours

• Postoperative pain score

  Postoperative 2 (resting only), 6, 24, 48 hours

• Count of rescue analgesics administration

  Postoperative 0-2, 2-6, 6-24, 24-48 hours

• Opioid side effects

  Postoperative 0-2, 2-6, 6-24, 24-48 hours

• Quality of recovery-15

  Postoperative 24 hours

Study Arms (2)

Preemptive administration group

EXPERIMENTAL

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

Preventive administration group

ACTIVE COMPARATOR

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

Interventions

Acetaminophen/Ibuprofen fixed-dose combination DRUG

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

Also known as: Maxigesic

Preemptive administration group; Preventive administration group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Kyongbo Pharmaceutical: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, KS013, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Hojin Lee, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An investigator who is not involved in this study randomly allocates the group and another investigator who dose not evaluate clinical endpoints keeps the result of allocation in a sealed envelope. On the day of study, the second investigator opens the envelope to check allocation and sends a drug and normal saline in identical looking bottles with label only indicating the order of administration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective randomized double-blinded study

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 17, 2023
• Study Start: February 10, 2023
• Primary Completion: February 28, 2025
• Study Completion: July 30, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

KR (1)