Bowel Function After Laparoscopic Colon Surgery: Effect of IV Lidocaine

Colon Cancer Clinical Trial

Official title:

Restoration of Bowel Function After Laparoscopic Colorectal Surgery: Effect of Intravenous Lidocaine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155440
• Other study ID #: GEN-06-023(1)
• Status: Completed
• Phase: Phase 2
• First received: June 30, 2010
• Last updated: November 24, 2011
• Start date: June 2009
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colon Cancer
• Diverticulitis
• Inflammatory Bowel Diseases

Intervention

Drug:
• Lidocaine
1% Lidocaine 1mg/kg/hr IV drip x 48hr

Procedure:
• Thoracic epidural block
0.1% Epidural bupivacaine + Morphine 0.02 mg/ml drip via epidural x48 hr

Locations

Country	Name	City	State
Canada	MUHC	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Restoration of bowel function		72 hours after an operation	No
Secondary	Pain intensity	Visual analog score pain (from 0-10) at rest, on walking and coughing at 24, 48 and 72 hours after an operation are assessed.	within 72 hours after an operation	No