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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
HO Kim, MD, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier:
NCT01346917
First received: April 29, 2011
Last updated: October 15, 2012
Last verified: October 2012
  Purpose

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.

Condition Intervention
Colorectal Cancer
Drug: Lidocaine
Drug: Normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official 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

Resource links provided by NLM:


Further study details as provided by Kangbuk Samsung Hospital:

Primary Outcome Measures:
  • Prevalence of postoperative nausea and vomiting. [ Time Frame: From day of surgery to sixth postoperative day. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Time to first flatus. [ Time Frame: From day of surgery to sixth postoperative day. ] [ Designated as safety issue: No ]
  • Time to first passage of stool. [ Time Frame: From day of surgery to sixth postoperative day. ] [ Designated as safety issue: No ]
  • Degree of postoperative pain. [ Time Frame: From day of surgery to sixth postoperative day. ] [ Designated as safety issue: No ]
  • Postoperative opioid consumption. [ Time Frame: From day of surgery to sixth postoperative day. ] [ Designated as safety issue: No ]
  • Time to tolerance of regular diet [ Time Frame: From day of surgery to sixth postoperative day. ] [ Designated as safety issue: No ]
  • Postoperative complications [ Time Frame: From day of surgery to thirtieth postoperative day. ] [ Designated as safety issue: No ]
  • Duration of postoperative hospital stay. [ Time Frame: From day of surgery until discharge, an expected average of nine days. ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: April 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidocaine Drug: Lidocaine
Lidocaine 1mg/kg(loading dose, just before skin incision) and lidocaine(in normal saline, total 240cc) 1mg/kg/hr with ketorolac 90mg for 24hrs.
Placebo Comparator: Placebo Drug: Normal saline
Normal saline 5cc(loading dose, just before skin incision) and normal saline 240cc with ketorolac 90mg for 24hrs.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346917

Locations
Korea, Republic of
Hyung Ook Kim
Seoul, Korea, Republic of, 110-746
Sponsors and Collaborators
Kangbuk Samsung Hospital
Investigators
Principal Investigator: Hyung Ook Kim, M.D Kangbuk Samsung Hospital
  More Information

No publications provided

Responsible Party: HO Kim, MD, Assistant professor, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier: NCT01346917     History of Changes
Other Study ID Numbers: KHO10-1
Study First Received: April 29, 2011
Last Updated: October 15, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Kangbuk Samsung Hospital:
Colorectal cancer
Laparoscopic surgery
Postoperative ileus
Lidocaine
Early oral feeding

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014