Back to resultsComparison of the Effects of Continuous Epidural Analgesia and Continuous Intravenous Analgesia on Postoperative Bowel Movement in Patients Undergoing Laparoscopic Gastrectomy
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
continuous epidural analgesia
continuous intravenous analgesia
Sponsored by
About this trial
This is an interventional other trial for Gastric Cancer
Eligibility Criteria
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)
Sites / Locations
- Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
continuous epidural analgesia group
continuous intravenous analgesia group
Arm Description
Outcomes
Primary Outcome Measures
the time to first gas passing after surgery
Outcome will be assessed by a investigator blinded to the study group.
the time to resume water intake after surgery
Outcome will be assessed by a investigator blinded to the study group.
soft diet intake after surgery
Outcome will be assessed by a investigator blinded to the study group.
Secondary Outcome Measures
postoperative pain
numerical rating scale 0 (no pain) to 10 (worst pain)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02458573
Brief Title
Comparison of the Effects of Continuous Epidural Analgesia and Continuous Intravenous Analgesia on Postoperative Bowel Movement in Patients Undergoing Laparoscopic Gastrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 4, 2015 (Actual)
Primary Completion Date
March 28, 2016 (Actual)
Study Completion Date
March 28, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
continuous epidural analgesia group
Arm Type
Experimental
Arm Title
continuous intravenous analgesia group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
continuous epidural analgesia
Intervention Description
the continuous epidural analgesia group: epidural analgesia started from induction of anesthesia and continued for 48 h.
Intervention Type
Other
Intervention Name(s)
continuous intravenous analgesia
Intervention Description
the continuous intravenous analgesia group: intravenous analgesia started from induction of anesthesia and continued for 48 h.
Primary Outcome Measure Information:
Title
the time to first gas passing after surgery
Description
Outcome will be assessed by a investigator blinded to the study group.
Time Frame
within 5days after surgery
Title
the time to resume water intake after surgery
Description
Outcome will be assessed by a investigator blinded to the study group.
Time Frame
within 5days after surgery
Title
soft diet intake after surgery
Description
Outcome will be assessed by a investigator blinded to the study group.
Time Frame
within 5days after surgery
Secondary Outcome Measure Information:
Title
postoperative pain
Description
numerical rating scale 0 (no pain) to 10 (worst pain)
Time Frame
immediately after surgery to 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
150-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Effects of Continuous Epidural Analgesia and Continuous Intravenous Analgesia on Postoperative Bowel Movement in Patients Undergoing Laparoscopic Gastrectomy
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