Effect of Intravenous Lidocaine on the Tolerability of Early Oral Feeding After Laparoscopic Colorectal Surgery

Colorectal Cancer Clinical Trial

Official title:

Prospective Randomized Controlled Study for the Effect of Intravenous Lidocaine on the Tolerability of Early Oral Feeding After Laparoscopic Colorectal Surgery in Patients With Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01346917
• Other study ID #: KHO10-1
• Status: Completed
• Phase: N/A
• First received: April 29, 2011
• Last updated: October 15, 2012
• Start date: April 2011
• Est. completion date: June 2012

Study information

• Verified date: October 2012
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Lidocaine
Lidocaine 1mg/kg(loading dose, just before skin incision) and lidocaine(in normal saline, total 240cc) 1mg/kg/hr with ketorolac 90mg for 24hrs.
• Normal saline
Normal saline 5cc(loading dose, just before skin incision) and normal saline 240cc with ketorolac 90mg for 24hrs.

Locations

Country	Name	City	State
Korea, Republic of	Hyung Ook Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of postoperative nausea and vomiting.	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.	From day of surgery to sixth postoperative day.	No
Secondary	Time to first flatus.		From day of surgery to sixth postoperative day.	No
Secondary	Time to first passage of stool.		From day of surgery to sixth postoperative day.	No
Secondary	Degree of postoperative pain.		From day of surgery to sixth postoperative day.	No
Secondary	Postoperative opioid consumption.		From day of surgery to sixth postoperative day.	No
Secondary	Time to tolerance of regular diet		From day of surgery to sixth postoperative day.	No
Secondary	Postoperative complications		From day of surgery to thirtieth postoperative day.	No
Secondary	Duration of postoperative hospital stay.		From day of surgery until discharge, an expected average of nine days.	No