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

Maxigesic_Pre

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.

2023-02-27

2024-08-30

2024-09-30

Recruiting

154

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective randomized double-blinded study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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.\n\nOn 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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 154, 'type': 'ESTIMATED'}}

2023-08-22