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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

June 30, 2010
November 24, 2011
June 2009
October 2011   (final data collection date for primary outcome measure)
Restoration of bowel function [ Time Frame: 72 hours after an operation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01155440 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Bowel Function After Laparoscopic Colon Surgery: Effect of IV Lidocaine
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
  • Colon Cancer
  • Inflammatory Bowel Diseases
  • Diverticulitis
  • 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
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01155440
GEN-06-023(1)
No
Gabriele Baldini, Assistant Professor, McGill University Health Center
McGill University Health Center
Not Provided
Principal Investigator: Mingkwan Wongyingsinn, Fellow McGill University Health Center
McGill University Health Center
November 2011

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