The Comparison Between Epidural and Intravenous Patient-c... | NCT02444897

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

NCT02444897

Sponsor

Keimyung University Dongsan Medical Center

Status

Completed

Last Update Posted

May 15, 2015Estimated

Enrollment

60Actual

Phase

Phase 3

Conditions

Gastric Cancer

Interventions

Epidural PCA Ropivacaine
IV PCA Fentanyl+nefopam+Ramosetron

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Apr 25, 2015

First Submission Date that Met QC Criteria

May 14, 2015

First Posted Date

May 15, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2015

Last Update Posted Date

May 15, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Seung Wan Ryu, Director of Gastrointesinal surgery, associate professor, Keimyung University Dongsan Medical CenterPrincipal Investigator

Lead Sponsor

Keimyung University Dongsan Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Epidural PCA group	Experimental	Epidural patient-controlled analgesia group	Drug: Epidural PCA Ropivacaine
IV PCA group	Active Comparator	Intravenous patient-controlled analgesia	Drug: IV PCA Fentanyl+nefopam+Ramosetron

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Epidural PCA Ropivacaine	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Seung Wan Ryu, M.D., Ph.D.	Director of gastrointestinal surgery devision, associate proffessor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Keimyung University Dongsan Medical Center		Daegu		700-712	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016058	Analgesia, Patient-Controlled

Ancestor Terms

ID	Term
D000698	Analgesia
D000760	Anesthesia and Analgesia

Browse Leaves

Not provided

Browse Branches

Not provided