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Comparison of preemptive and preventive intravenous acetaminophen/ibuprofen combination in hand-assisted laparoscopic nephrectomy

Comparison of the opioid-sparing effect of preemptive and preventive intravenous acetaminophen/ibuprofen fixed-dose combination after hand-assisted laparoscopic nephrectomy: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009290
Enrollment
42
Registered
2024-03-29
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Timing of drug administration) : In the preemptive group, acetaminophen 1000 mg / ibuprofen 300 mg is administered intravenously over 15 minutes just before the start of surgery. In the prevent

Sponsors

Ajou University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A. Patients aged 19 to 80 years undergoing hand-assisted laparoscopic nephrectomy B. Patients who can provide written consent to participate in the clinical study, understand the procedures of this clinical study, and appropriately complete the patient-reported questionnaire. C. American Society of Anesthesiologists physical status classification (ASA physical status classification) grade 1-2

Exclusion criteria

Exclusion criteria: A. Patients who did not consent to the study B. American Society of Anesthesiologists physical status classification (ASA physical status classification) grade 3-4 C. Patients who are chronically taking opioids D. Patients who have other severe pain at the time of screening, which may cause confusion in pain evaluation E. Patients with hypersensitivity to acetaminophen, ibuprofen, fentanyl, or local anesthetics F. Patients with a history of gastric ulcer or gastrointestinal bleeding G. Patients with liver failure, renal failure, or heart failure H. Patients with alcoholism I. Patients taking anticoagulant drugs or having blood coagulation abnormalities J. Patients with bronchial asthma K. Patients with a history of hypersensitivity such as asthma, urticaria, or allergic reaction to aspirin or other non-steroidal anti-inflammatory drugs (including CoX-2 inhibitors) L. Patients who find it difficult to complete an abbreviated post-anesthesia recovery questionnaire M. Patients taking the following drugs: barbiturates, tricyclic antidepressants N. Patients deemed unsuitable for this clinical study according to the opinion of the researcher

Design outcomes

Primary

MeasureTime frame
Total opioid use (morphine equivalents) up to 24 hours postoperatively

Secondary

MeasureTime frame
Total opioid use (morphine equivalents) up to 30 minutes, 6, and 48 hours postoperatively;Pain intensity at rest/movement assessed using an 11-point NRS pain score at 30 minutes, 6, 24, and 48 hours postoperatively;Dose of opioids administered via patient controlled analgesia up to 6, 24, and 48 hours postoperatively;Number and dose of rescue analgesics administered up to 30 minutes, 6, 24, and 48 hours postoperatively;Incidence of nausea/vomiting and rescue antiemetic administration within 30 minutes after surgery;Incidence of opioid-related adverse events such as nausea, vomiting, hypotension, dizziness, sedation, and respiratory depression 24 and 48 hours after surgery (%);Quality of recovery-15 score (0-150) at 24 hours postoperatively

Countries

Korea, Republic of

Contacts

Public ContactJinyoung Bae

Ajou University Hospital

baejy88@gmail.com+82-31-219-6433

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026