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Trial record 99 of 317 for:    colon cancer | ( Map: Canada )

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

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ClinicalTrials.gov Identifier: NCT00982618
Recruitment Status : Completed
First Posted : September 23, 2009
Last Update Posted : November 28, 2011
Sponsor:
Information provided by (Responsible Party):
Gabriele Baldini, Assistant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.


Condition or disease Intervention/treatment Phase
Colon Cancer Inflammatory Bowel Diseases Diverticulitis Drug: Lidocaine Procedure: Epidural Block Drug: PCA Morphine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post Operative Functional Restoration in Patients Undergoing Major Abdominal and Pelvic Laparoscopic Surgery: Effect of Perioperative Intravenous Lidocaine
Study Start Date : July 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LIDOCAINE group
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: Intravenous local anesthetic infusion

Experimental: Epidural Group
Epidural Group: Beside general anesthesia, patient will receive epidural freezing medication for 48 hours.
Procedure: Epidural Block
0.1% Epidural bupivacaine + Morphine 0.02 mg/ml drip via epidural x48 hr
Other Name: Thoracic epidural analgesia

Active Comparator: PCA group
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.
Drug: PCA Morphine
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.
Other Name: Patient Control Analgesia Morphine.




Primary Outcome Measures :
  1. Postoperative functional recovery [ Time Frame: daily during hospitalization, and at 4 and 8 weeks after the surgery ]

Secondary Outcome Measures :
  1. postoperative pain [ Time Frame: daily during hospitalization ]
  2. opioid consumption [ Time Frame: daily during hospitalization ]
  3. opioid side effects [ Time Frame: daily during hospitalization ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982618


Locations
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Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
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Principal Investigator: Franco Carli, Professor McGill University Healt Centre

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Responsible Party: Gabriele Baldini, Assistant Professor, Dr, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT00982618     History of Changes
Other Study ID Numbers: GEN-06-023
First Posted: September 23, 2009    Key Record Dates
Last Update Posted: November 28, 2011
Last Verified: November 2011
Additional relevant MeSH terms:
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Diverticulitis
Inflammatory Bowel Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Gastroenteritis
Diverticular Diseases
Intraabdominal Infections
Infection
Lidocaine
Morphine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics