Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kyongbo Pharmaceutical | UNKNOWN |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen/Ibuprofen fixed-dose combination | Drug | Intravenous administration of Acetaminophen (1000 mg)/Ibuprofen (300 mg) fixed-dose combination (total 100 ml) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total fentanyl consumption during 24 hours | Postoperative fentanyl consumption (mcg) via IV patient controlled analgesia | Postoperative 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total fentanyl consumption | Postoperative fentanyl consumption (mcg) via IV patient controlled analgesia (PCA) | 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" |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hojin Lee, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Seoul | KS013 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41790365 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
A prospective randomized double-blinded study
Not provided
Not provided
An investigator who is not involved in this study randomly allocates the group and another investigator who dose not evaluate clinical endpoints keeps the result of allocation in a sealed envelope.
On the day of study, the second investigator opens the envelope to check allocation and sends a drug and normal saline in identical looking bottles with label only indicating the order of administration.
|
| 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 | 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 (%) | 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" | Postoperative 24 hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |