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

Seoul National University

Status: Completed

Conditions: Postoperative Pain

Treatments: Drug: Acetaminophen/Ibuprofen fixed-dose combination

Study type: Interventional

Funder types: Other

Identifiers

NCT05685342

Maxigesic_Pre

Details and patient eligibility

About

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.

Full 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.

Enrollment: 154 patients

Sex: Male

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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154 participants in 2 patient groups

Preemptive administration group

Experimental group

Description:

Preemptive administration group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 minutes at the end of induction of anesthesia.

Treatment:

Drug: Acetaminophen/Ibuprofen fixed-dose combination

Preventive administration group

Active Comparator group

Description:

The preventive administration group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 minutes when surgical site closure starts.

Treatment:

Drug: Acetaminophen/Ibuprofen fixed-dose combination