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

January 24, 2017 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 150-752
        • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: continuous epidural analgesia group
Other: continuous epidural analgesia
the continuous epidural analgesia group: epidural analgesia started from induction of anesthesia and continued for 48 h.
Active Comparator: continuous intravenous analgesia group
Other: continuous intravenous analgesia
the continuous intravenous analgesia group: intravenous analgesia started from induction of anesthesia and continued for 48 h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the time to first gas passing after surgery
Time Frame: within 5days after surgery
Outcome will be assessed by a investigator blinded to the study group.
within 5days after surgery
the time to resume water intake after surgery
Time Frame: within 5days after surgery
Outcome will be assessed by a investigator blinded to the study group.
within 5days after surgery
soft diet intake after surgery
Time Frame: within 5days after surgery
Outcome will be assessed by a investigator blinded to the study group.
within 5days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain
Time Frame: immediately after surgery to 48 hours
numerical rating scale 0 (no pain) to 10 (worst pain)
immediately after surgery to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2015

Primary Completion (Actual)

March 28, 2016

Study Completion (Actual)

March 28, 2016

Study Registration Dates

First Submitted

May 26, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (Estimate)

June 1, 2015

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2015-0157

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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