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

Seoul National University Hospital154 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

154

Conditions

Postoperative Pain

Interventions

Acetaminophen/Ibuprofen fixed-dose combinationDRUG

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

Eligibility

Sex: MALEMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, Seoul, South Korea

Outcomes

Primary Outcomes

Total fentanyl consumption during 24 hours

Postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

Time frame: Postoperative 24 hours

Secondary Outcomes

Total fentanyl consumption

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

Time frame: 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"

Time frame: 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

Time frame: 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 (%)

Time frame: 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"

Time frame: Postoperative 24 hours

Data from ClinicalTrials.gov

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