Bowel Function After Laparoscopic Colon Surgery: Effect of IV Lidocaine

Phase 2

Completed

• Conditions: Colon Cancer; Inflammatory Bowel Diseases; Diverticulitis
• Interventions: Procedure: Thoracic epidural block; Drug: Lidocaine

• Registration Number: NCT01155440
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

Patients receiving perioperative intravenous lidocaine, post operative restoration of bowel movement will be faster and decrease pain intensity, opioid consumption and side effects, length of hospital stay; probably as a result of a significant opioid sparing and attenuated inflammatory response.

Detailed Description

The aim of this study is to assess whether perioperative intravenous lidocaine has an impact on the early postoperative physical activity recovery of patients scheduled for laparoscopic colorectal resection.

The study focuses on patients with colorectal disease, which receive the laparoscopic (assisted) surgical approach.

It is hypothesized that in those patients receiving perioperative and post-operative intravenous lidocaine, bowel function recovery will be faster, probably as a result of a significant opioid sparing, less pain and attenuated inflammatory response.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-06-30
• Study First Submitted QC: 2010-06-30
• Study First Posted: 2010-07-01
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-24
• Last Update Posted: 2011-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• scheduled to undergo laparoscopic colorectal resection

Exclusion Criteria

• patients who have trouble to understand, read or communicate either in French or in English
• dementia
• patients suffering from severe physical disability (arthritis, neuromuscular dysfunction, stroke, paraplegia) or inability to walk or conduct daily activity
• patients suffering from severe cardiac or respiratory disease (status ASA IV
• patients suffering from metastatic carcinoma
• patients who have a history of chemoradiation within the six months preceding surgery
• allergy to lidocaine
• morbid obesity
• patients with chronic opioid use.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural group	Thoracic epidural block	Beside general anesthesia, patient will receive epidural freezing medication for 48 hours.
LIDOCAINE group	Lidocaine	Beside general anesthesia, patients will receive intravenous lidocaine bolus 1.5 mg/kg just prior induction and an infusion of lidocaine 2mg/kg/h will be started and maintained during the whole surgical procedure. Entering the recovery room, this infusion will be decreased at the rate of 1mg/kg/hour for the 48 first hours

Primary Outcome Measures

Name	Time	Method
Restoration of bowel function	72 hours after an operation

Secondary Outcome Measures

Name	Time	Method
Pain intensity	within 72 hours after an operation	Visual analog score pain (from 0-10) at rest, on walking and coughing at 24, 48 and 72 hours after an operation are assessed.

Trial Locations

Locations (1)

MUHC; 🇨🇦 Montreal, Quebec, Canada