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NCT Number: NCT01346917

Effect of Intravenous Lidocaine on the Tolerability of Early Oral Feeding After Laparoscopic Colorectal Surgery

The purpose of this study is to determine whether intravenous lidocaine increase the tolerability of early oral feeding after laparoscopic colorectal surgery in patients with colorectal cancer.

* Degree of nausea/vomiting. * Degree of postoperative pain and opioids requirement. * Time to first flatus, time to first stool, time to tolerance of regular diet, rate of postoperative complications and duration of postoperative hospital stay.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hyung Ook Kim

Seoul, 110-746, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elective laparoscopic colorectal surgery for colorectal cancer.
  • Age > 18 years.
  • Informed consent.

Exclusion criteria

  • Allergy to local anesthetics.
  • Severe cardiovascular, hepatic, or renal diseases.
  • Pregnant or lactating patients.
  • Emergency surgery.
  • American Society of Anesthesiologists (ASA) class IV

Treatment and study plan

Lidocaine

Drug

Lidocaine 1mg/kg(loading dose, just before skin incision) and lidocaine(in normal saline, total 240cc) 1mg/kg/hr with ketorolac 90mg for 24hrs.

normal saline

Drug

Normal saline 5cc(loading dose, just before skin incision) and normal saline 240cc with ketorolac 90mg for 24hrs.

Primary outcomes

  1. Prevalence of postoperative nausea and vomiting.

    Time frame: From day of surgery to sixth postoperative day.

    Intolerance to early postoperative oral feeding is defined as the patient's having either nausea or vomiting, requiring that the patient be non-per oral status.

Secondary outcomes

  1. Time to first flatus.

    Time frame: From day of surgery to sixth postoperative day.

  2. Time to first passage of stool.

    Time frame: From day of surgery to sixth postoperative day.

  3. Degree of postoperative pain.

    Time frame: From day of surgery to sixth postoperative day.

  4. Postoperative opioid consumption.

    Time frame: From day of surgery to sixth postoperative day.

  5. Time to tolerance of regular diet

    Time frame: From day of surgery to sixth postoperative day.

  6. Postoperative complications

    Time frame: From day of surgery to thirtieth postoperative day.

  7. Duration of postoperative hospital stay.

    Time frame: From day of surgery until discharge, an expected average of nine days.

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Registry information

Official study title

Prospective Randomized Controlled Study for the Effect of Intravenous Lidocaine on the Tolerability of Early Oral Feeding After Laparoscopic Colorectal Surgery in Patients With Colorectal Cancer

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 3, 2011
Registry last updated
Oct 17, 2012

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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