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Bowel Function After Laparoscopic Colon Surgery: Effect of IV Lidocaine

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ClinicalTrials.gov Identifier: NCT01155440
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : November 28, 2011
Sponsor:
Information provided by (Responsible Party):
Gabriele Baldini, Assistant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colon Cancer Inflammatory Bowel Diseases Diverticulitis Drug: Lidocaine Procedure: Thoracic epidural block Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Restoration of Bowel Function After Laparoscopic Colorectal Surgery: Effect of Intravenous Lidocaine
Study Start Date : June 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arms and Interventions
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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 Name: 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 Name: Thoracic Epidural analgesia


Outcome Measures
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Primary Outcome Measures :
  1. Restoration of bowel function [ Time Frame: 72 hours after an operation ]

Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155440


Locations
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Canada, Quebec
MUHC
Montreal, Quebec, Canada, H3G1A4
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
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Principal Investigator: Mingkwan Wongyingsinn, Fellow McGill University Health Centre/Research Institute of the McGill University Health Centre
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gabriele Baldini, Assistant Professor, Dr, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT01155440    
Other Study ID Numbers: GEN-06-023(1)
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: November 28, 2011
Last Verified: November 2011
Keywords provided by Gabriele Baldini, Assistant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre:
60 patients scheduled to have a colorectal surgery
recruit at Montreal General Hospital
Additional relevant MeSH terms:
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Diverticulitis
Inflammatory Bowel Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Gastroenteritis
Diverticular Diseases
Intraabdominal Infections
Infection
Lidocaine
Anesthetics, Local
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action