Patients undergoing laparoscopic colorectal surgery
Conditions
Interventions
Epidural Analgesia(EDA)
Intravenous infusion of acetaminophen
Sponsors
Kitasato University
Anesthesiology , Kitasato University School of Medicine Clinical Trial Center, Kitasato University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must fulfill all of the following inclusion criteria and be judged eligible for enrollment of the study by the investigator. 1) Subjects diagnosed as colonial disease with the need of surgery and having laparoscopic colorectal surgery. 2) Subjects who do not need simultaneous resection of multiple lesions with preoperative medical evaluation by endoscopy and image inspection. 3) Subjects older than 20 years old when obtaining informed consent. 4) Subjects with sufficient function of main organs. 5) Subjects with a written, signed, and dated informed consent for the study.
Exclusion criteria
Exclusion criteria: Subjects are excluded from the study by the following criteria. The investigator must ensure the criteria at the time of enrollment unless otherwise specified. 1) Any subjects with a past history of anaphylaxis due to acetaminophen. 2) Any subjects contraindicated to use acetaminophen. 3) Any subjects with conditions of severe hepatic, renal, and heart dysfunction, and infections. 4) Any subjects assumed to be adversely affected by pharmacological effects of acetaminophen. 5) Any subjects assumed to have difficulty in epidural analgesia. 6) Any subjects with high possibility of need for abdominal surgery during laparoscopic colorectal surgery. 7) Any subjects judged not eligible for enrollment of the study other than any of the above reasons by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medical recovery is determined by the following criteria. 1. Recovery of motor function (period of time required for the status at least comparable with the one in preoperative time, or period of time required for the first time walking after surgery) 2. Recovery of the function of digestive system (period of time required for the first time feces and flatus after surgery). 3. Pain control (period of time required for the switch to oral analgesia, and the number of time subjects use analgesics) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Influence on inflammatory response following laparoscopic colorectal surgery 2. Adverse effect | — |
Countries
Japan
Contacts
Public ContactHirohisa Miura
Kitasato University School of Medicine Depretment of Surgery
Outcome results
None listed