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

NCT00982618 | Completed DMC

• 1 other identifier: GEN-06-023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer; Inflammatory Bowel Diseases; Diverticulitis

Outcome Measures

Primary Outcomes (1)

• Postoperative functional recovery

  daily during hospitalization, and at 4 and 8 weeks after the surgery

Secondary Outcomes (3)

• postoperative pain

  daily during hospitalization

• opioid consumption

  daily during hospitalization

• opioid side effects

  daily during hospitalization

Study Arms (3)

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

Drug: Lidocaine

Epidural Group

EXPERIMENTAL

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

Procedure: Epidural Block

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.

Drug: PCA Morphine

Interventions

Lidocaine DRUG

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

Also known as: Intravenous local anesthetic infusion

LIDOCAINE group

Epidural Block PROCEDURE

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

Also known as: Thoracic epidural analgesia

Epidural Group

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.

Also known as: Patient Control Analgesia Morphine.

PCA group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients scheduled to undergo laparoscopic colonic resection

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Colonic Neoplasms; Inflammatory Bowel Diseases; Diverticulitis

Interventions

Lidocaine; Anesthesia, Epidural; Tea

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Gastroenteritis; Diverticular Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Franco Carli, Professor

  McGill University Healt Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 23, 2009
• Study Start: July 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2011
• Last Updated: November 28, 2011

Record last verified: 2011-11

Locations

CA (1)