Bowel Function After Laparoscopic Colon Surgery: Effect of IV Lidocaine

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Gabriele Baldini, Assistant Professor, McGill University Health Center

ClinicalTrials.gov Identifier:

NCT01155440

First received: June 30, 2010

Last updated: November 24, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 30, 2010

Last Updated Date

November 24, 2011

Start Date ^ICMJE

June 2009

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Restoration of bowel function [ Time Frame: 72 hours after an operation ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01155440 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pain intensity [ Time Frame: within 72 hours after an operation ] [ Designated as safety issue: No ]

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bowel Function After Laparoscopic Colon Surgery: Effect of IV Lidocaine

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care

Condition ^ICMJE

Colon Cancer
Inflammatory Bowel Diseases
Diverticulitis

Intervention ^ICMJE

Drug: Lidocaine
1% Lidocaine 1mg/kg/hr IV drip x 48hr

Other Name: Xylocaine
Procedure: Thoracic epidural block
0.1% Epidural bupivacaine + Morphine 0.02 mg/ml drip via epidural x48 hr

Other Name: Thoracic Epidural analgesia

Study Arm (s)

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

Intervention: Drug: Lidocaine
Active Comparator: Epidural group
Beside general anesthesia, patient will receive epidural freezing medication for 48 hours.

Intervention: Procedure: Thoracic epidural block

Publications *

Wongyingsinn M, Baldini G, Charlebois P, Liberman S, Stein B, Carli F. Intravenous lidocaine versus thoracic epidural analgesia: a randomized controlled trial in patients undergoing laparoscopic colorectal surgery using an enhanced recovery program. Reg Anesth Pain Med. 2011 May-Jun;36(3):241-8.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2011

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01155440

Other Study ID Numbers ^ICMJE

GEN-06-023(1)

Has Data Monitoring Committee

Responsible Party

Gabriele Baldini, Assistant Professor, McGill University Health Center

Study Sponsor ^ICMJE

McGill University Health Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Mingkwan Wongyingsinn, Fellow

McGill University Health Center

Information Provided By

McGill University Health Center

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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