Text Size

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
History of Changes

April 29, 2011
October 15, 2012
April 2011
June 2012   (final data collection date for primary outcome measure)
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.
Prevalence and severity of postoperative nausea and vomiting. [ Time Frame: From day of surgery to sixth postoperative day. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01346917 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Time to first flatus and first passage of stool. [ Time Frame: From day of surgery to sixth postoperative day. ] [ Designated as safety issue: No ]
  • Degree of postoperative pain and opioid consumption. [ 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 ]
  • Time to tolerance of regular diet [ Time Frame: From day of surgery to sixth 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 ]
Not Provided
Not Provided
 
Effect of Intravenous Lidocaine on the Tolerability of Early Oral Feeding After Laparoscopic Colorectal Surgery
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

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Colorectal Cancer
  • 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.
  • Drug: Normal saline
    Normal saline 5cc(loading dose, just before skin incision) and normal saline 240cc with ketorolac 90mg for 24hrs.
  • Experimental: Lidocaine
    Intervention: Drug: Lidocaine
  • Placebo Comparator: Placebo
    Intervention: Drug: Normal saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01346917
KHO10-1
Yes
HO Kim, MD, Kangbuk Samsung Hospital
Kangbuk Samsung Hospital
Not Provided
Principal Investigator: Hyung Ook Kim, M.D Kangbuk Samsung Hospital
Kangbuk Samsung Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP