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

NCT ID: NCT02444897

Last Updated: 2015-05-15

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

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-12-31

Brief Summary

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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.

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

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Epidural PCA group

Epidural patient-controlled analgesia group

Group Type EXPERIMENTAL

Epidural PCA Ropivacaine

Intervention Type DRUG

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

IV PCA group

Intravenous patient-controlled analgesia

Group Type ACTIVE_COMPARATOR

IV PCA Fentanyl+nefopam+Ramosetron

Intervention Type DRUG

Total volume: 84ml, Fentanyl 1000mcg+nefopam 120mg+Ramosetron 0.3mg Basal infusion: 1ml/hr, Bolus: 0.5ml with a lockout time 15min.

Interventions

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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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Epidural patient-controlled analgesia Ropivacaine intravenous patient-controlled analgesia

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Keimyung University Dongsan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Seung Wan Ryu

Director of Gastrointesinal surgery, associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seung Wan Ryu, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Director of gastrointestinal surgery devision, associate proffessor

Locations

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Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2012-12-514

Identifier Type: -

Identifier Source: org_study_id

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