Bowel Function After Laparoscopic Colon Surgery: Effect of IV Lidocaine

November 24, 2011 updated by: Gabriele Baldini, Assistant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre

Restoration of Bowel Function After Laparoscopic Colorectal Surgery: Effect of Intravenous Lidocaine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G1A4
        • MUHC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LIDOCAINE group
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
Drug: Lidocaine
1% Lidocaine 1mg/kg/hr IV drip x 48hr
Other Names:
  • Xylocaine
Active Comparator: Epidural group
Beside general anesthesia, patient will receive epidural freezing medication for 48 hours.
Procedure: Thoracic epidural block
0.1% Epidural bupivacaine + Morphine 0.02 mg/ml drip via epidural x48 hr
Other Names:
  • Thoracic Epidural analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Restoration of bowel function
Time Frame: 72 hours after an operation
72 hours after an operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 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.
within 72 hours after an operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

  • Principal Investigator: Mingkwan Wongyingsinn, Fellow, McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

June 30, 2010

First Submitted That Met QC Criteria

June 30, 2010

First Posted (Estimate)

July 1, 2010

Study Record Updates

Last Update Posted (Estimate)

November 28, 2011

Last Update Submitted That Met QC Criteria

November 24, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEN-06-023(1)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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