Thoracic Epidural for Postoperative Ileus

Not Applicable

Completed

• Conditions: Ileus
• Interventions: Drug: iv-PCA; Procedure: thoracic epidural analgesia

• Registration Number: NCT02491385
• Lead Sponsor: Samsung Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Study First Submitted: 2015-06-30
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-02
• Last Update Submitted: 2015-07-02
• Study First Posted: 2015-07-08
• Last Update Posted: 2015-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iv-PCA	iv-PCA	intravenous patient controlled analgesia group
TEA	thoracic epidural analgesia	thoracic epidural analgesia group

Primary Outcome Measures

Name	Time	Method
gas out time	from operation to post operative 10 days

Secondary Outcome Measures

Name	Time	Method
voiding time	from operation to post operative 10 days
numeric rating scale for pain	from operation to post operative 3 days

Trial Locations

Locations (1)

Samsung medical center; 🇰🇷 Seoul, Korea, Republic of