orthopedic disease Orthopedic surgery
Conditions
Interventions
For the acetaminophen treated group, acetaminophen is administered as a postoperative analgesic at a dose of 1000 mg intravenously over 15 minutes at the time of wound closure for patients weighing 50
Acetaminophen, open-label
Sponsors
Nakashima Hiroaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Over 18 years old Patients undergoing orthopedic surgery under general anesthesia The patient must understand the study and give written consent. Patients must be able to maintain major organ function and meet all of the following criteria (1) AST Less than 5 times the upper limit of the institutional reference value (2) ALT Less than 5 times the upper limit of the institutional reference value (3) Total bilirubin Less than 3 times the upper limit of the institutional reference value (4) Creatinine Less than 3 times the upper limit of the institutional reference value (5) No occurrence of events that, in the judgment of the investigator, would make it difficult to administer the study drug.
Exclusion criteria
Exclusion criteria: Symptoms of Grade 3 or higher (CTCAE v5.0) or abnormal laboratory values Patients with a history of hypersensitivity or intolerance to acetaminophen or NSAIDs Patients with a history of hypersensitivity or intolerance to acetaminophen or NSAIDs. Patients with peptic ulcer. Patients with serious blood disorders. Patients with serious hepatic disorder. Patients with serious renal failure. Patients with serious cardiac dysfunction. Patients with aspirin asthma (non-steroidal anti-inflammatory analgesics induced asthma attack) or a history of aspirin asthma. Patients who are judged by the principal investigator to be unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of delirium according to CAM Japanese version | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative pain VAS (6, 24, 48 hours, 3, 7 days postoperatively) Therapeutic acetaminophen administration up to 48 hours postoperatively for acetaminophen non-treatment group Total opioid dose during hospitalization Time from postoperative to discharge Presence of psychiatric intervention at the time of delirium | — |
Contacts
Public ContactSadayuki Ito
Orthopedic Surgery
Outcome results
None listed