Bowel Function After Laparoscopic Colon Surgery: Effect of IV Lidocaine
NCT ID: NCT01155440
Last Updated: 2011-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2009-06-30
2011-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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
Lidocaine
1% Lidocaine 1mg/kg/hr IV drip x 48hr
Epidural group
Beside general anesthesia, patient will receive epidural freezing medication for 48 hours.
Thoracic epidural block
0.1% Epidural bupivacaine + Morphine 0.02 mg/ml drip via epidural x48 hr
Interventions
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Lidocaine
1% Lidocaine 1mg/kg/hr IV drip x 48hr
Thoracic epidural block
0.1% Epidural bupivacaine + Morphine 0.02 mg/ml drip via epidural x48 hr
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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Gabriele Baldini, Assistant Professor
Dr
Principal Investigators
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Mingkwan Wongyingsinn, Fellow
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Locations
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MUHC
Montreal, Quebec, Canada
Countries
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References
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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.
Other Identifiers
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GEN-06-023(1)
Identifier Type: -
Identifier Source: org_study_id