Thoracic Epidural for Postoperative Ileus
Effect of Thoracic Epidural Analgesia on Bowel Function Recovery in Major Upper Abdominal Surgeries
1 other identifier
interventional
28
1 country
1
Brief Summary
The investigators try to find whether thoracic epidural analgesia (TEA) shortens the first gas-out time compared to iv-PCA and promotes earlier discharge after major upper abdominal surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2014
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
Study Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 30, 2015
CompletedFirst Posted
Study publicly available on registry
July 8, 2015
CompletedJuly 8, 2015
July 1, 2015
11 months
June 30, 2015
July 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
gas out time
from operation to post operative 10 days
Secondary Outcomes (2)
voiding time
from operation to post operative 10 days
numeric rating scale for pain
from operation to post operative 3 days
Study Arms (2)
TEA
EXPERIMENTALthoracic epidural analgesia group
iv-PCA
ACTIVE COMPARATORintravenous patient controlled analgesia group
Interventions
In a sitting position, an 18-gauge Tuohy needle is introduced at T6-7 or T7-8 intervertebral space using a paramedian approach. An epidural catheter is advanced 5 cm beyond the tip of the needle and secured with a sterile dressing. For TEA regimen, hydromorphone (8 mcg/ml) was added to 0.15% ropivacaine. TEA setting was bolus/lock out time/basal, 3 ml/15 min/5 ml.
iv-PCA setting was fentanyl 20 mcg/ml, bolus/lock out time/basal, 0.5 ml/15 min/0.5 ml.
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists' (ASA) physical statusⅠ-Ⅲ
You may not qualify if:
- ASA status of Ⅳ, or more
- Body mass index 30 kg.m2-1 or more
- Severe renal, hepatic, or neurologic diseases
- Opioid or systemic analgesic preoperatively
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung medical center
Seoul, 135-710, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyun Joo Ahn, Professor
Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
June 30, 2015
First Posted
July 8, 2015
Study Start
April 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
July 8, 2015
Record last verified: 2015-07