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

Not Applicable
Conditions
Not Applicable
Registration Number
KCT0009290
Lead Sponsor
Ajou University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
All
Target Recruitment
42
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

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

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Total opioid use (morphine equivalents) up to 24 hours postoperatively
Secondary Outcome Measures
NameTimeMethod
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
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