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Bowel Function After Laparoscopic Colon Surgery: Effect of IV Lidocaine

Primary Purpose

Colon Cancer, Inflammatory Bowel Diseases, Diverticulitis

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Lidocaine
Thoracic epidural block
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colon Cancer focused on measuring 60 patients scheduled to have a colorectal surgery, recruit at Montreal General Hospital

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MUHC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LIDOCAINE group

Epidural group

Arm Description

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

Beside general anesthesia, patient will receive epidural freezing medication for 48 hours.

Outcomes

Primary Outcome Measures

Restoration of bowel function

Secondary Outcome Measures

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

Full Information

First Posted
June 30, 2010
Last Updated
November 24, 2011
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01155440
Brief Title
Bowel Function After Laparoscopic Colon Surgery: Effect of IV Lidocaine
Official Title
Restoration of Bowel Function After Laparoscopic Colorectal Surgery: Effect of Intravenous Lidocaine
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Inflammatory Bowel Diseases, Diverticulitis
Keywords
60 patients scheduled to have a colorectal surgery, recruit at Montreal General Hospital

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LIDOCAINE group
Arm Type
Experimental
Arm Description
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
Arm Title
Epidural group
Arm Type
Active Comparator
Arm Description
Beside general anesthesia, patient will receive epidural freezing medication for 48 hours.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Xylocaine
Intervention Description
1% Lidocaine 1mg/kg/hr IV drip x 48hr
Intervention Type
Procedure
Intervention Name(s)
Thoracic epidural block
Other Intervention Name(s)
Thoracic Epidural analgesia
Intervention Description
0.1% Epidural bupivacaine + Morphine 0.02 mg/ml drip via epidural x48 hr
Primary Outcome Measure Information:
Title
Restoration of bowel function
Time Frame
72 hours after an operation
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Visual analog score pain (from 0-10) at rest, on walking and coughing at 24, 48 and 72 hours after an operation are assessed.
Time Frame
within 72 hours after an operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingkwan Wongyingsinn, Fellow
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
MUHC
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G1A4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21519309
Citation
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. doi: 10.1097/AAP.0b013e31820d4362.
Results Reference
derived

Learn more about this trial

Bowel Function After Laparoscopic Colon Surgery: Effect of IV Lidocaine

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