Colorectal Cancer
Conditions
Keywords
Colorectal cancer, Laparoscopic surgery, Postoperative ileus, Lidocaine, Early oral feeding
Brief summary
The purpose of this study is to determine whether intravenous lidocaine increase the tolerability of early oral feeding after laparoscopic colorectal surgery in patients with colorectal cancer. * Degree of nausea/vomiting. * Degree of postoperative pain and opioids requirement. * Time to first flatus, time to first stool, time to tolerance of regular diet, rate of postoperative complications and duration of postoperative hospital stay.
Interventions
DRUGLidocaine
Lidocaine 1mg/kg(loading dose, just before skin incision) and lidocaine(in normal saline, total 240cc) 1mg/kg/hr with ketorolac 90mg for 24hrs.
DRUGNormal saline
Normal saline 5cc(loading dose, just before skin incision) and normal saline 240cc with ketorolac 90mg for 24hrs.
Sponsors
Kangbuk Samsung Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elective laparoscopic colorectal surgery for colorectal cancer. * Age \> 18 years. * Informed consent.
Exclusion criteria
* Allergy to local anesthetics. * Severe cardiovascular, hepatic, or renal diseases. * Pregnant or lactating patients. * Emergency surgery. * American Society of Anesthesiologists (ASA) class IV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of postoperative nausea and vomiting. | From day of surgery to sixth postoperative day. | Intolerance to early postoperative oral feeding is defined as the patient's having either nausea or vomiting, requiring that the patient be non-per oral status. |
Secondary
| Measure | Time frame |
|---|---|
| Time to first passage of stool. | From day of surgery to sixth postoperative day. |
| Degree of postoperative pain. | From day of surgery to sixth postoperative day. |
| Postoperative opioid consumption. | From day of surgery to sixth postoperative day. |
| Time to first flatus. | From day of surgery to sixth postoperative day. |
| Postoperative complications | From day of surgery to thirtieth postoperative day. |
| Duration of postoperative hospital stay. | From day of surgery until discharge, an expected average of nine days. |
| Time to tolerance of regular diet | From day of surgery to sixth postoperative day. |
Countries
South Korea
Outcome results
None listed