Back to results

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

Primary Purpose

Colorectal Cancer

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Lidocaine

Normal saline

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring Colorectal cancer, Laparoscopic surgery, Postoperative ileus, Lidocaine, Early oral feeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hyung Ook Kim

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to first flatus.

Time to first passage of stool.

Degree of postoperative pain.

Postoperative opioid consumption.

Time to tolerance of regular diet

Postoperative complications

Duration of postoperative hospital stay.

Full Information

NCT ID

NCT01346917

First Posted

April 29, 2011

Last Updated

October 15, 2012

Sponsor

Kangbuk Samsung Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01346917

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kangbuk Samsung Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

Colorectal cancer, Laparoscopic surgery, Postoperative ileus, Lidocaine, Early oral feeding

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

77 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lidocaine

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Normal saline

Intervention Description

Normal saline 5cc(loading dose, just before skin incision) and normal saline 240cc with ketorolac 90mg for 24hrs.

Primary Outcome Measure Information:

Title

Prevalence of postoperative nausea and vomiting.

Description

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.

Time Frame