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Thoracic Epidural for Postoperative Ileus

Primary Purpose

Ileus

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
thoracic epidural analgesia
iv-PCA
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ileus focused on measuring Thoracic epidural analgesia, bowel function recovery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists' (ASA) physical statusⅠ-Ⅲ

Exclusion Criteria:

  • 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

Sites / Locations

  • Samsung medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TEA

iv-PCA

Arm Description

thoracic epidural analgesia group

intravenous patient controlled analgesia group

Outcomes

Primary Outcome Measures

gas out time

Secondary Outcome Measures

voiding time
numeric rating scale for pain

Full Information

First Posted
June 30, 2015
Last Updated
July 2, 2015
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02491385
Brief Title
Thoracic Epidural for Postoperative Ileus
Official Title
Effect of Thoracic Epidural Analgesia on Bowel Function Recovery in Major Upper Abdominal Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Postoperative ileus (POI) is a prolonged inhibition of coordinated bowel activity after surgery. Half of patients undergoing major abdominal surgery experience POI making it one of the limiting factors for early recovery. The pathogenesis of POI is multifactorial, and includes neurogenic, inflammatory and pharmacological mechanisms. Thoracic epidural analgesia (TEA) can induce sympathetic block, attenuate inflammatory reaction and limit use of systemic opioids. In addition, sympatholysis induced by TEA can improve microcirculation of bowels and parasympathetic activation can increase gastrointestinal motility. However, studies comparing TEA and iv-PCA on POI are rare in major upper abdominal surgeries. This study, therefore, compares TEA and iv-PCA in terms of bowel function recovery as a primary endpoint in major upper abdominal surgeries. Secondary endpoints are side effects and hospital stay.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileus
Keywords
Thoracic epidural analgesia, bowel function recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TEA
Arm Type
Experimental
Arm Description
thoracic epidural analgesia group
Arm Title
iv-PCA
Arm Type
Active Comparator
Arm Description
intravenous patient controlled analgesia group
Intervention Type
Procedure
Intervention Name(s)
thoracic epidural analgesia
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
iv-PCA
Intervention Description
iv-PCA setting was fentanyl 20 mcg/ml, bolus/lock out time/basal, 0.5 ml/15 min/0.5 ml.
Primary Outcome Measure Information:
Title
gas out time
Time Frame
from operation to post operative 10 days
Secondary Outcome Measure Information:
Title
voiding time
Time Frame
from operation to post operative 10 days
Title
numeric rating scale for pain
Time Frame
from operation to post operative 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists' (ASA) physical statusⅠ-Ⅲ Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Joo Ahn, Professor
Organizational Affiliation
Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung medical center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

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Thoracic Epidural for Postoperative Ileus

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