Postoperative PainNCT05685342
Preemptive and Preventive Acetaminophen/Ibuprofen Fixed-dose Combination After Robot-assisted Radical Prostatectomy
A study testing Acetaminophen/Ibuprofen fixed-dose combination in people with Postoperative Pain, run by Seoul National University Hospital at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages 19 to 80 years, men only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Acetaminophen/Ibuprofen fixed-dose combination
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Feb 2023to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Acetaminophen/Ibuprofen fixed-dose combination
- Keywords
- Postoperative Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen/Ibuprofen fixed-dose combinationDrug
Also called Maxigesic
Intravenous administration of Acetaminophen (1000 mg)/Ibuprofen (300 mg) fixed-dose combination (total 100 ml)
| Study group | Role | What they receive |
|---|---|---|
| Preemptive administration group | Experimental | Preemptive administration group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 minutes at the end of induction of anesthesia. Receives: Drug: Acetaminophen/Ibuprofen fixed-dose combination |
| Preventive administration group | Active comparator | The preventive administration group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 minutes when surgical site closure starts. Receives: Drug: Acetaminophen/Ibuprofen fixed-dose combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total fentanyl consumption during 24 hours
Postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
Measured: Postoperative 24 hours
Secondary outcomes (5)
Total fentanyl consumption
Postoperative fentanyl consumption (mcg) via IV patient controlled analgesia (PCA)
Measured: Postoperative 2, 6, 48 hours
Postoperative pain score
11-pointed NRS pain score at resting/coughing NRS (0-10): 0,"no pain"; 10, "worst pain imaginable"
Measured: Postoperative 2 (resting only), 6, 24, 48 hours
Count of rescue analgesics administration
Number of count of rescue analgesics administered because of patient's request for additional analgesia than IV PCA
Measured: Postoperative 0-2, 2-6, 6-24, 24-48 hours
Opioid side effects
Incidence of opioid side effects like postoperative nausea/vomiting, hypotension, dizziness, somnolence and respiratory depression (%)
Measured: Postoperative 0-2, 2-6, 6-24, 24-48 hours
Quality of recovery-15
Korean version of Quality of recovery-15 questionnaire (0-150): 0, "very poor recovery"; 150, "excellent recovery"
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start10 Feb 2023
- Primary completion28 Feb 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective randomized double-blinded study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kyongbo Pharmaceutical
- Responsible party
- Principal investigator, Hojin Lee, MD, PhD, Seoul National University Hospital
- Investigators
- Hojin Lee, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685342
- Sponsor's protocol ID
- Maxigesic_Pre
- Status last verified
- Sep 2025
- First submitted
- 5 Jan 2023
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Youssof HA, Hassan AA, Saleh AA, Shafiea A, Mohammed AM, Elsayed AS, Metwally ME, Abdelkhalek NA, Hassan GM, Elebiary MF, Lotfy AA, Sharawy A. Preemptive versus preventive intravenous acetaminophen/ibuprofen fixed-dose combination after robot-assisted radical prostatectomy: a comprehensive secondary analysis of a public double-blind randomized dataset. J Robot Surg. 2026 Mar 6;20(1):320. doi: 10.1007/s11701-026-03239-2.
PubMed 41790365
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05685342
- Acronym / sponsor ID
- Maxigesic_Pre
- Conditions
- Postoperative Pain
- Keywords
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Kyongbo Pharmaceutical
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective randomized double-blinded study
| Arm | Type | Receives |
|---|---|---|
| Preemptive administration group | Experimental | Drug: Acetaminophen/Ibuprofen fixed-dose combinationPreemptive administration group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 minutes at the end of induction of anesthesia. |
| Preventive administration group | Active comparator | Drug: Acetaminophen/Ibuprofen fixed-dose combinationThe preventive administration group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 minutes when surgical site closure starts. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetaminophen/Ibuprofen fixed-dose combinationAlso: MaxigesicIntravenous administration of Acetaminophen (1000 mg)/Ibuprofen (300 mg) fixed-dose combination (total 100 ml) | Drug | Preemptive administration group, Preventive administration group |
Primary outcome
Total fentanyl consumption during 24 hours
Time frame: Postoperative 24 hours
Postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
5 secondary outcomes
Total fentanyl consumption
Time frame: Postoperative 2, 6, 48 hours
Postoperative pain score
Time frame: Postoperative 2 (resting only), 6, 24, 48 hours
Count of rescue analgesics administration
Time frame: Postoperative 0-2, 2-6, 6-24, 24-48 hours
Opioid side effects
Time frame: Postoperative 0-2, 2-6, 6-24, 24-48 hours
Quality of recovery-15
Time frame: Postoperative 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Derived from this study: PubMed 41790365Youssof HA, Hassan AA, Saleh AA, Shafiea A, Mohammed AM, Elsayed AS, Metwally ME, Abdelkhalek NA, Hassan GM, Elebiary MF, Lotfy AA, Sharawy A. Preemptive versus preventive intravenous acetaminophen/ibuprofen fixed-dose combination after robot-assisted radical prostatectomy: a comprehensive secondary analysis of a public double-blind randomized dataset. J Robot Surg. 2026 Mar 6;20(1):320. doi: 10.1007/s11701-026-03239-2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hojin Lee, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetaminophen/Ibuprofen fixed-dose combination in people with Postoperative Pain, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total fentanyl consumption during 24 hours (time frame: Postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05685342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.