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Thoracic Epidural for Postoperative Ileus

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Samsung Medical Center

Status

Completed

Conditions

Ileus

Treatments

Drug: iv-PCA
Procedure: thoracic epidural analgesia

Study type

Interventional

Funder types

Other

Identifiers

NCT02491385
2014-12-129

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

28 participants in 2 patient groups

TEA
Experimental group
Description:
thoracic epidural analgesia group
Treatment:
Procedure: thoracic epidural analgesia
iv-PCA
Active Comparator group
Description:
intravenous patient controlled analgesia group
Treatment:
Drug: iv-PCA

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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