NCT01155440

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

November 28, 2011

Status Verified

November 1, 2011

Enrollment Period

2.3 years

First QC Date

June 30, 2010

Last Update Submit

November 24, 2011

Conditions

Colon CancerInflammatory Bowel DiseasesDiverticulitis

Keywords

60 patients scheduled to have a colorectal surgeryrecruit at Montreal General Hospital

Outcome Measures

Primary Outcomes (1)

  • Restoration of bowel function

    72 hours after an operation

Secondary Outcomes (1)

  • Pain intensity

    within 72 hours after an operation

Study Arms (2)

LIDOCAINE group

EXPERIMENTAL

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

Epidural group

ACTIVE COMPARATOR

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

Procedure: Thoracic epidural block

Interventions

LidocaineDRUG

1% Lidocaine 1mg/kg/hr IV drip x 48hr

Also known as: Xylocaine
LIDOCAINE group
Thoracic epidural blockPROCEDURE

0.1% Epidural bupivacaine + Morphine 0.02 mg/ml drip via epidural x48 hr

Also known as: Thoracic Epidural analgesia
Epidural group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • scheduled to undergo laparoscopic colorectal resection

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MUHC

Montreal, Quebec, H3G1A4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 21519309DERIVED

MeSH Terms

Conditions

Colonic NeoplasmsInflammatory Bowel DiseasesDiverticulitis

Interventions

LidocaineTea

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesGastroenteritisDiverticular Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPlant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Mingkwan Wongyingsinn, Fellow

    McGill University Health Centre/Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 30, 2010

First Posted

July 1, 2010

Study Start

June 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

November 28, 2011

Record last verified: 2011-11

Locations

CA(1)