Comparison of the Effects of Continuous Epidural Analgesia and Continuous Intravenous Analgesia on Postoperative Bowel Movement in Patients Undergoing Laparoscopic Gastrectomy
1 other identifier
interventional
86
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 gastric-cancer
Started Jun 2015
Shorter than P25 for phase_4 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2015
CompletedFirst Posted
Study publicly available on registry
June 1, 2015
CompletedStudy Start
First participant enrolled
June 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2016
CompletedJanuary 25, 2017
January 1, 2017
10 months
May 26, 2015
January 24, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
the time to first gas passing after surgery
Outcome will be assessed by a investigator blinded to the study group.
within 5days after surgery
the time to resume water intake after surgery
Outcome will be assessed by a investigator blinded to the study group.
within 5days after surgery
soft diet intake after surgery
Outcome will be assessed by a investigator blinded to the study group.
within 5days after surgery
Secondary Outcomes (1)
postoperative pain
immediately after surgery to 48 hours
Study Arms (2)
continuous epidural analgesia group
EXPERIMENTALcontinuous intravenous analgesia group
ACTIVE COMPARATORInterventions
the continuous epidural analgesia group: epidural analgesia started from induction of anesthesia and continued for 48 h.
the continuous intravenous analgesia group: intravenous analgesia started from induction of anesthesia and continued for 48 h.
Eligibility Criteria
You may qualify if:
- patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ
- gastric cancer patient undergoing laparoscopic gastrectomy
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, Seoul, 150-752, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2015
First Posted
June 1, 2015
Study Start
June 4, 2015
Primary Completion
March 28, 2016
Study Completion
March 28, 2016
Last Updated
January 25, 2017
Record last verified: 2017-01