Back to resultsThe Comparison Between Epidural and Intravenous Patient-controlled Analgesia for Laparoscopic Gastrectomy
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Epidural PCA Ropivacaine
IV PCA Fentanyl+nefopam+Ramosetron
Sponsored by
About this trial
This is an interventional supportive care trial for Gastric Cancer focused on measuring Gastric cancer, epidural, PCA, laparoscopy
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
Sites / Locations
- Keimyung University Dongsan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Epidural PCA group
IV PCA group
Arm Description
Epidural patient-controlled analgesia group
Intravenous patient-controlled analgesia
Outcomes
Primary Outcome Measures
VAS score
pain degree was checked at every 24hours for 5days after operation
Secondary Outcome Measures
number of participants with complication
PCA related complication
Bowel motility
by counting Colomark on abdomen x-ray
Full Information
NCT ID
NCT02444897
First Posted
April 25, 2015
Last Updated
May 14, 2015
Sponsor
Keimyung University Dongsan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02444897
Brief Title
The Comparison Between Epidural and Intravenous Patient-controlled Analgesia for Laparoscopic Gastrectomy
Official Title
The Comparison Between Epidural and Intravenous Patient-controlled Analgesia for Laparoscopic Gastrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keimyung University Dongsan Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric cancer, epidural, PCA, laparoscopy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epidural PCA group
Arm Type
Experimental
Arm Description
Epidural patient-controlled analgesia group
Arm Title
IV PCA group
Arm Type
Active Comparator
Arm Description
Intravenous patient-controlled analgesia
Intervention Type
Drug
Intervention Name(s)
Epidural PCA Ropivacaine
Other Intervention Name(s)
Epidural patient-controlled analgesia Ropivacaine
Intervention Description
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
Intervention Name(s)
IV PCA Fentanyl+nefopam+Ramosetron
Other Intervention Name(s)
intravenous patient-controlled analgesia
Intervention Description
Total volume: 84ml, Fentanyl 1000mcg+nefopam 120mg+Ramosetron 0.3mg Basal infusion: 1ml/hr, Bolus: 0.5ml with a lockout time 15min.
Primary Outcome Measure Information:
Title
VAS score
Description
pain degree was checked at every 24hours for 5days after operation
Time Frame
24 hours after operation
Secondary Outcome Measure Information:
Title
number of participants with complication
Description
PCA related complication
Time Frame
for 5days after operation
Title
Bowel motility
Description
by counting Colomark on abdomen x-ray
Time Frame
for 5days after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung Wan Ryu, M.D., Ph.D.
Organizational Affiliation
Director of gastrointestinal surgery devision, associate proffessor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Comparison Between Epidural and Intravenous Patient-controlled Analgesia for Laparoscopic Gastrectomy
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