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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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.
- Postoperative functional recovery [ Time Frame: daily during hospitalization, and at 4 and 8 weeks after the surgery ]
- postoperative pain [ Time Frame: daily during hospitalization ]
- opioid consumption [ Time Frame: daily during hospitalization ]
- opioid side effects [ Time Frame: daily during hospitalization ]
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
|Montreal General Hospital|
|Montreal, Quebec, Canada, H3G 1A4|
|Principal Investigator:||Franco Carli, Professor||McGill University Healt Centre|