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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05685342
• Other study ID #: Maxigesic_Pre
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: August 2023
• Source: Seoul National University Hospital
• Contact: Hojin Lee, PhD
• Phone: 82-2-2072-2467
• Email: zenerdiode03[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: September 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Kyongbo Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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