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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Post Operative Functional Restoration in Patients Undergoing Major Abdominal and Pelvic Laparoscopic Surgery: Effect of Perioperative Intravenous Lidocaine

Conditions
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Colon Cancer, Inflammatory Bowel Diseases, Diverticulitis

Intervention / Treatment
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* Drug: Lidocaine
* Procedure: Epidural Block
* Drug: PCA Morphine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIDOCAINE group<br>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<br>* 1% Lidocaine 1mg/kg/hr IV drip x 48hr<br>* Other names: Intravenous local anesthetic infusion;|
| Experimental: Epidural Group<br>Epidural Group: Beside general anesthesia, patient will receive epidural freezing medication for 48 hours. | Procedure: Epidural Block<br>* 0.1% Epidural bupivacaine + Morphine 0.02 mg/ml drip via epidural x48 hr<br>* Other names: Thoracic epidural analgesia;|
| Active Comparator: PCA group<br>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<br>* 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.<br>* Other names: Patient Control Analgesia Morphine.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative functional recovery |  | daily during hospitalization, and at 4 and 8 weeks after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain |  | daily during hospitalization | 
| opioid consumption |  | daily during hospitalization | 
| opioid side effects |  | daily during hospitalization |