Text Size

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
  Purpose

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 Intervention Phase
Colon Cancer
Inflammatory Bowel Diseases
Diverticulitis
 Drug: Lidocaine
Procedure: Thoracic epidural block
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Restoration of Bowel Function After Laparoscopic Colorectal Surgery: Effect of Intravenous Lidocaine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

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

Secondary Outcome Measures:
  • 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.


Enrollment: 60
Study Start Date: June 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155440

Locations
Canada, Quebec
MUHC
Montreal, Quebec, Canada, H3G1A4
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Mingkwan Wongyingsinn, Fellow McGill University Health Center
  More Information

No publications provided by McGill University Health Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gabriele Baldini, Assistant Professor, Dr, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01155440     History of Changes
Other Study ID Numbers: GEN-06-023(1)
Study First Received: June 30, 2010
Last Updated: November 24, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
60 patients scheduled to have a colorectal surgery
recruit at Montreal General Hospital

Additional relevant MeSH terms:
Colonic Neoplasms
Diverticulitis
Inflammatory Bowel Diseases
Intestinal Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
 Gastroenteritis
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013