Bowel Function After Laparoscopic Colon Surgery: Effect of IV Lidocaine
|ClinicalTrials.gov Identifier: NCT01155440|
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : November 28, 2011
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer Inflammatory Bowel Diseases Diverticulitis||Drug: Lidocaine Procedure: Thoracic epidural block||Phase 2|
The aim of this study is to assess whether perioperative intravenous lidocaine has an impact on the early postoperative physical activity recovery of patients scheduled for laparoscopic colorectal resection.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Restoration of Bowel Function After Laparoscopic Colorectal Surgery: Effect of Intravenous Lidocaine|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
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
1% Lidocaine 1mg/kg/hr IV drip x 48hr
Other Name: Xylocaine
Active Comparator: Epidural group
Beside general anesthesia, patient will receive epidural freezing medication for 48 hours.
Procedure: Thoracic epidural block
0.1% Epidural bupivacaine + Morphine 0.02 mg/ml drip via epidural x48 hr
Other Name: Thoracic Epidural analgesia
- Restoration of bowel function [ Time Frame: 72 hours after an operation ]
- Pain intensity [ Time Frame: within 72 hours after an operation ]Visual analog score pain (from 0-10) at rest, on walking and coughing at 24, 48 and 72 hours after an operation are assessed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155440
|Montreal, Quebec, Canada, H3G1A4|
|Principal Investigator:||Mingkwan Wongyingsinn, Fellow||McGill University Health Center|