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

NCT ID: NCT01346917

Last Updated: 2012-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Keywords

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Colorectal cancer Laparoscopic surgery Postoperative ileus Lidocaine Early oral feeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Lidocaine

Group Type EXPERIMENTAL

Lidocaine

Intervention Type 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.

Placebo

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kangbuk Samsung Hospital

OTHER

Sponsor Role lead

Responsible Party

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HO Kim, MD

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyung Ook Kim, M.D

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital

Locations

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Hyung Ook Kim

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 24612414 (View on PubMed)

Other Identifiers

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KHO10-1

Identifier Type: -

Identifier Source: org_study_id