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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIDOCAINE group | Experimental | 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 | Experimental | Epidural Group: Beside general anesthesia, patient will receive epidural freezing medication for 48 hours. |
|
| PCA group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | 1% Lidocaine 1mg/kg/hr IV drip x 48hr |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative functional recovery | daily during hospitalization, and at 4 and 8 weeks after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain | daily during hospitalization | |
| opioid consumption | daily during hospitalization | |
| opioid side effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franco Carli, Professor | McGill University Healt Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal General Hospital | Montreal | Quebec | H3G 1A4 | Canada |
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| Epidural Block | Procedure | 0.1% Epidural bupivacaine + Morphine 0.02 mg/ml drip via epidural x48 hr |
|
|
| PCA Morphine | Drug | 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. |
|
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| daily during hospitalization |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D015212 | Inflammatory Bowel Diseases |
| D004238 | Diverticulitis |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005759 | Gastroenteritis |
| D000076385 | Diverticular Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000767 | Anesthesia, Epidural |
| D013662 | Tea |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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