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

NCT01346917 | Completed DMC

• 1 other identifier: KHO10-1
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

Colorectal cancer; Laparoscopic surgery; Postoperative ileus; Lidocaine; Early oral feeding

Outcome Measures

Primary Outcomes (1)

• Prevalence of postoperative nausea and vomiting.

  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.

  From day of surgery to sixth postoperative day.

Secondary Outcomes (7)

• Time to first flatus.

  From day of surgery to sixth postoperative day.

• Time to first passage of stool.

  From day of surgery to sixth postoperative day.

• Degree of postoperative pain.

  From day of surgery to sixth postoperative day.

• Postoperative opioid consumption.

  From day of surgery to sixth postoperative day.

• Time to tolerance of regular diet

  From day of surgery to sixth postoperative day.

Study Arms (2)

Lidocaine

EXPERIMENTAL

Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

Drug: Normal saline

Interventions

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.

Lidocaine

Normal saline DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead

Study Sites (1)

Hyung Ook Kim

Seoul, 110-746, South Korea

Location

Related Publications (1)

• Kim HO, Lee SR, Choi WJ, Kim H. Early oral feeding following laparoscopic colorectal cancer surgery. ANZ J Surg. 2014 Jul-Aug;84(7-8):539-44. doi: 10.1111/ans.12550. Epub 2014 Feb 24.

  PMID: 24612414 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hyung Ook Kim, M.D

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 3, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 17, 2012

Record last verified: 2012-10

Locations

KR (1)