Clinical trial NCT05685342: Preemptive and Preventive Acetaminophen/Ibuprofen Fixed-dose Combination After Robot-assisted Radical Prostatectomy
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Postoperative Pain
Keywords: Postoperative Pain
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Kyongbo Pharmaceutical
First posted: 2023-01-17
Enrollment: 154
Sex: MALE
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective randomized double-blinded study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Total fentanyl consumption during 24 hours
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Total fentanyl consumption
timeFrame: Postoperative 2, 6, 48 hours
measure: Postoperative pain score
timeFrame: Postoperative 2 (resting only), 6, 24, 48 hours
measure: Count of rescue analgesics administration
timeFrame: Postoperative 0-2, 2-6, 6-24, 24-48 hours
measure: Opioid side effects
timeFrame: Postoperative 0-2, 2-6, 6-24, 24-48 hours
measure: Quality of recovery-15
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hojin Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: