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

NCT ID: NCT00982618

Last Updated: 2011-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2011-06-30

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.

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.

Conditions

Colon Cancer; Inflammatory Bowel Diseases; Diverticulitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

1% Lidocaine 1mg/kg/hr IV drip x 48hr

Epidural Group

Epidural Group: Beside general anesthesia, patient will receive epidural freezing medication for 48 hours.

Group Type: EXPERIMENTAL

Epidural Block

Intervention Type: PROCEDURE

0.1% Epidural bupivacaine + Morphine 0.02 mg/ml drip via epidural x48 hr

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.

Group Type: ACTIVE_COMPARATOR

PCA Morphine

Intervention Type: 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.

Interventions

Lidocaine

1% Lidocaine 1mg/kg/hr IV drip x 48hr

Intervention Type: DRUG

Epidural Block

0.1% Epidural bupivacaine + Morphine 0.02 mg/ml drip via epidural x48 hr

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Other Intervention Names

Intravenous local anesthetic infusion; Thoracic epidural analgesia; Patient Control Analgesia Morphine.

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Gabriele Baldini, Assistant Professor

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Franco Carli, Professor

Role: PRINCIPAL_INVESTIGATOR

McGill University Healt Centre

Locations

Montreal General Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

GEN-06-023

Identifier Type: -

Identifier Source: org_study_id