Bowel Function After Laparoscopic Colon Surgery: Effect of IV Lidocaine

McGill University

Status and phase: Completed; Phase 2

Conditions: Colon Cancer; Inflammatory Bowel Diseases; Diverticulitis

Treatments: Procedure: Thoracic epidural block; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01155440

GEN-06-023(1)

Details and patient eligibility

About

Patients receiving perioperative intravenous lidocaine, post operative restoration of bowel movement 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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• scheduled to undergo laparoscopic colorectal 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
• patients with chronic opioid use.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

LIDOCAINE group

Experimental group

Description:

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

Treatment:

Drug: Lidocaine

Epidural group

Active Comparator group

Description:

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

Treatment:

Procedure: Thoracic epidural block