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OpenTrials
Completed

NCT Number: NCT01155440

Bowel Function After Laparoscopic Colon Surgery: Effect of IV Lidocaine

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Diverticular Diseases Diverticulitis Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Inflammatory Bowel Diseases Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MUHC

Montreal, Quebec, H3G1A4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine

Drug

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

Other names: Xylocaine

Thoracic epidural block

Procedure

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

Other names: Thoracic Epidural analgesia

Primary outcomes

  1. Restoration of bowel function

    Time frame: 72 hours after an operation

Secondary outcomes

  1. Pain intensity

    Time frame: within 72 hours after an operation

    Visual analog score pain (from 0-10) at rest, on walking and coughing at 24, 48 and 72 hours after an operation are assessed.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 1, 2010
Registry last updated
Nov 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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