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

Not Applicable

Active, not recruiting

• Conditions: Postoperative Pain
• Interventions: Drug: Acetaminophen/Ibuprofen fixed-dose combination

• Registration Number: NCT05685342
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2023-01-05
• Study First Submitted QC: 2023-01-05
• Study First Posted: 2023-01-17
• Study Start: 2023-02-27
• Primary Completion: 2025-02-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preventive administration group	Acetaminophen/Ibuprofen fixed-dose combination	The preventive administration group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 minutes when surgical site closure starts.
Preemptive administration group	Acetaminophen/Ibuprofen fixed-dose combination	Preemptive administration group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 minutes at the end of induction of anesthesia.

Primary Outcome Measures

Name	Time	Method
Total fentanyl consumption during 24 hours	Postoperative 24 hours	Postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

Secondary Outcome Measures

Name	Time	Method
Count of rescue analgesics administration	Postoperative 0-2, 2-6, 6-24, 24-48 hours	Number of count of rescue analgesics administered because of patient's request for additional analgesia than IV PCA
Postoperative pain score	Postoperative 2 (resting only), 6, 24, 48 hours	11-pointed NRS pain score at resting/coughing NRS (0-10): 0,"no pain"; 10, "worst pain imaginable"
Opioid side effects	Postoperative 0-2, 2-6, 6-24, 24-48 hours	Incidence of opioid side effects like postoperative nausea/vomiting, hypotension, dizziness, somnolence and respiratory depression (%)
Quality of recovery-15	Postoperative 24 hours	Korean version of Quality of recovery-15 questionnaire (0-150): 0, "very poor recovery"; 150, "excellent recovery"
Total fentanyl consumption	Postoperative 2, 6, 48 hours	Postoperative fentanyl consumption (mcg) via IV patient controlled analgesia (PCA)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of