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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05685342
Collaborator
Kyongbo Pharmaceutical (Other)
154
Enrollment
1
Location
2
Arms
9.7
Anticipated Duration (Months)
15.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Acetaminophen/Ibuprofen fixed-dose combination
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
154 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A prospective randomized double-blinded studyA prospective randomized double-blinded study
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Treatment
Official 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
Anticipated Study Start Date :
Jan 9, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total fentanyl consumption during 24 hours [Postoperative 24 hours]

      Postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

    Secondary Outcome Measures

    1. Total fentanyl consumption [Postoperative 2, 6, 48 hours]

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

    2. Postoperative pain score [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 [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 [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 [Postoperative 24 hours]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of KS013

    Sponsors and Collaborators

    • Seoul National University Hospital
    • Kyongbo Pharmaceutical

    Investigators

    • Principal Investigator: Hojin Lee, PhD, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hojin Lee, MD, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT05685342
    Other Study ID Numbers:
    • Maxigesic_Pre
    First Posted:
    Jan 17, 2023
    Last Update Posted:
    Jan 17, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hojin Lee, MD, Professor, Seoul National University Hospital
    Postoperative Pain
    Additional relevant MeSH terms:
    Pain, Postoperative
    Acetaminophen
    Ibuprofen

    Study Results

    No Results Posted as of Jan 17, 2023