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

NCT ID: NCT05685342

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-10
• Study Completion Date: 2025-07-30

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.

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Acetaminophen/Ibuprofen fixed-dose combination

Intervention Type: DRUG

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

Preventive administration group

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

Group Type: ACTIVE_COMPARATOR

Acetaminophen/Ibuprofen fixed-dose combination

Intervention Type: DRUG

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

Interventions

Acetaminophen/Ibuprofen fixed-dose combination

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

Intervention Type: DRUG

Other Intervention Names

Maxigesic

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Kyongbo Pharmaceutical

UNKNOWN

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hojin Lee, MD, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hojin Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

Maxigesic_Pre

Identifier Type: -

Identifier Source: org_study_id