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

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Normal saline; Drug: Lidocaine

• Registration Number: NCT01346917
• Lead Sponsor: Kangbuk Samsung Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-29
• Study First Submitted QC: 2011-05-02
• Study First Posted: 2011-05-03
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-15
• Last Update Posted: 2012-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Normal saline	-
Lidocaine	Lidocaine	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Time to first flatus.	From day of surgery to sixth postoperative day.
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 tolerance of regular diet	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.

Trial Locations

Locations (1)

Hyung Ook Kim; 🇰🇷 Seoul, Korea, Republic of