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Functional Restoration After Abdominal and Pelvic Laparoscopic Surgery: Effect of Perioperative Intravenous Lidocaine

Primary Purpose

Colon Cancer, Inflammatory Bowel Diseases, Diverticulitis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lidocaine
Epidural Block
PCA Morphine
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 treatment trial for Colon Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients scheduled to undergo laparoscopic colonic 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

Sites / Locations

  • Montreal General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

LIDOCAINE group

Epidural Group

PCA group

Arm Description

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

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

Beside general anesthesia, the patients will receive neither lidocaine nor epidural catheter. The patients will receive the same analgesia protocol consisting of PCA morphine for a total duration of 48 hours.

Outcomes

Primary Outcome Measures

Postoperative functional recovery

Secondary Outcome Measures

postoperative pain
opioid consumption
opioid side effects

Full Information

First Posted
September 22, 2009
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
NCT00982618
Brief Title
Functional Restoration After Abdominal and Pelvic Laparoscopic Surgery: Effect of Perioperative Intravenous Lidocaine
Official Title
Post Operative Functional Restoration in Patients Undergoing Major Abdominal and Pelvic Laparoscopic Surgery: Effect of Perioperative Intravenous Lidocaine
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 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
Yes

5. Study Description

Brief Summary
This is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. The aim of this study is to assess whether perioperative intravenous lidocaine has an impact on the early post operative physical activity recovery of patients scheduled for laparoscopic colon surgery. Twenty patients will receive thoracic epidural analgesia, twenty patients will receive intravenous lidocaine plus patient-controlled analgesia (PCA) and twenty patients will receive only PCA. Hypothesis: patients receiving perioperative intravenous lidocaine, post operative recovery 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
This is a blinded randomised study of patients undergoing major laparoscopic abdominal and pelvic surgery. The first group of patients will receive thoracic epidural analgesia, the second group will receive perioperative intravenous lidocaine, the third group will PCA alone and the last group will receive spinal analgesia. Functional restoration assessed by self-administered quality of Life questionnaires (SF-36, CHAMPS, ICFS) and 2 and 6 min walking test will be assessed in the two groups at 3 and 8 weeks after the surgery.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LIDOCAINE group
Arm Type
Experimental
Arm Description
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
Arm Title
Epidural Group
Arm Type
Experimental
Arm Description
Epidural Group: Beside general anesthesia, patient will receive epidural freezing medication for 48 hours.
Arm Title
PCA group
Arm Type
Active Comparator
Arm Description
Beside general anesthesia, the patients will receive neither lidocaine nor epidural catheter. The patients will receive the same analgesia protocol consisting of PCA morphine for a total duration of 48 hours.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Intravenous local anesthetic infusion
Intervention Description
1% Lidocaine 1mg/kg/hr IV drip x 48hr
Intervention Type
Procedure
Intervention Name(s)
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
Intervention Type
Drug
Intervention Name(s)
PCA Morphine
Other Intervention Name(s)
Patient Control Analgesia Morphine.
Intervention Description
PCA Morphine is set to the patient for 48 hours postoperative. 2 mg. of morphine is given to a patient as much as patient requires, maximum at every 7 minutes.
Primary Outcome Measure Information:
Title
Postoperative functional recovery
Time Frame
daily during hospitalization, and at 4 and 8 weeks after the surgery
Secondary Outcome Measure Information:
Title
postoperative pain
Time Frame
daily during hospitalization
Title
opioid consumption
Time Frame
daily during hospitalization
Title
opioid side effects
Time Frame
daily during hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients scheduled to undergo laparoscopic colonic 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco Carli, Professor
Organizational Affiliation
McGill University Healt Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Functional Restoration After Abdominal and Pelvic Laparoscopic Surgery: Effect of Perioperative Intravenous Lidocaine

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