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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Acetaminophen/Ibuprofen fixed-dose combination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective randomized double-blinded study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preemptive administration group<br>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<br>* Intravenous administration of Acetaminophen (1000 mg)/Ibuprofen (300 mg) fixed-dose combination (total 100 ml)<br>* Other names: Maxigesic;|
| Active Comparator: Preventive administration group<br>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<br>* Intravenous administration of Acetaminophen (1000 mg)/Ibuprofen (300 mg) fixed-dose combination (total 100 ml)<br>* Other names: Maxigesic;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Pain