The Comparison Between Epidural and Intravenous Patient-controlled Analgesia for Laparoscopic Gastrectomy

May 14, 2015 updated by: Seung Wan Ryu, Keimyung University Dongsan Medical Center
This study was designed to assess the effectiveness of epidural patient-controlled analgesia compared to intravenous patient-controlled analgesia in patients undergoing laparoscopic gastrectomy. The investigators hypothesized that epidural PCA would be more effective in pain control than IV PCA even for laparoscopic gastrectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

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
      • Daegu, Korea, Republic of, 700-712
        • Keimyung University Dongsan Medical Center

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

19 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma in stomach
  • Males or Females, aged≥19 years and ≤80 years
  • Scheduled as laparoscopic gastrectomy
  • Patient has given their written informed consent to participate in the study

Exclusion Criteria:

  • History of hypersensitivity for analgesics
  • Recent history of narcotic analgesics
  • Disability of central nerve system
  • Uncontrolled co-morbidity

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epidural PCA group
Epidural patient-controlled analgesia group
Drug: Epidural PCA Ropivacaine

Epidural catheter insertion at T10 level before surgery, the tip of catheter location at T8-9 level.

Total volume: 500ml, 16.7mcg/kg+0.75% Ropivacaine 80ml+N/S

Other Names:
  • Epidural patient-controlled analgesia Ropivacaine
Active Comparator: IV PCA group
Intravenous patient-controlled analgesia
Drug: IV PCA Fentanyl+nefopam+Ramosetron
Total volume: 84ml, Fentanyl 1000mcg+nefopam 120mg+Ramosetron 0.3mg Basal infusion: 1ml/hr, Bolus: 0.5ml with a lockout time 15min.
Other Names:
  • intravenous patient-controlled analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS score
Time Frame: 24 hours after operation
pain degree was checked at every 24hours for 5days after operation
24 hours after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of participants with complication
Time Frame: for 5days after operation
PCA related complication
for 5days after operation
Bowel motility
Time Frame: for 5days after operation
by counting Colomark on abdomen x-ray
for 5days after operation

Collaborators and Investigators

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

Sponsor

Keimyung University Dongsan Medical Center

Investigators

  • Principal Investigator: Seung Wan Ryu, M.D., Ph.D., Director of gastrointestinal surgery devision, associate proffessor

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

September 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 25, 2015

First Submitted That Met QC Criteria

May 14, 2015

First Posted (Estimate)

May 15, 2015

Study Record Updates

Last Update Posted (Estimate)

May 15, 2015

Last Update Submitted That Met QC Criteria

May 14, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-12-514

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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