Comparison of the Effects of Continuous Epidural Analgesia and Continuous Intravenous Analgesia on Postoperative Bowel Movement in Patients Undergoing Laparoscopic Gastrectomy

NCT ID: NCT02458573

Last Updated: 2017-01-25

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

PHASE4

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-04

Study Completion Date

2016-03-28

Brief Summary

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The investigators hypothesized that sympatholytic effect of epidural analgesia would attenuate the hemodynamic instability and decrease in the splanchnic blood flow caused by pneumoperitoneum during laparoscopic surgery. This study is to compare the effect of epidural analgesia and intravenous analgesia on postoperative bowel movement in patients undergoing laparoscopic gastrectomy.

Detailed Description

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Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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continuous epidural analgesia group

Group Type EXPERIMENTAL

continuous epidural analgesia

Intervention Type OTHER

the continuous epidural analgesia group: epidural analgesia started from induction of anesthesia and continued for 48 h.

continuous intravenous analgesia group

Group Type ACTIVE_COMPARATOR

continuous intravenous analgesia

Intervention Type OTHER

the continuous intravenous analgesia group: intravenous analgesia started from induction of anesthesia and continued for 48 h.

Interventions

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continuous epidural analgesia

the continuous epidural analgesia group: epidural analgesia started from induction of anesthesia and continued for 48 h.

Intervention Type OTHER

continuous intravenous analgesia

the continuous intravenous analgesia group: intravenous analgesia started from induction of anesthesia and continued for 48 h.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ
* gastric cancer patient undergoing laparoscopic gastrectomy

Exclusion Criteria

* ASA physical status Ⅳ
* bradycardia (\< 60 bpm), arrhythmia
* uncompensated heart failure
* hepatic failure (Child-Pugh score B)
* renal failure (eGFR MDRD \< 60 ml/min/1.73m2)
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2015-0157

Identifier Type: -

Identifier Source: org_study_id

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