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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine<br> | Drug: Lidocaine<br>* Lidocaine 1mg/kg(loading dose, just before skin incision) and lidocaine(in normal saline, total 240cc) 1mg/kg/hr with ketorolac 90mg for 24hrs.<br>|
| Placebo Comparator: Placebo<br> | Drug: Normal saline<br>* Normal saline 5cc(loading dose, just before skin incision) and normal saline 240cc with ketorolac 90mg for 24hrs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Laparoscopic surgery, Postoperative ileus, Lidocaine, Early oral feeding