Thoracic Epidural for Postoperative Ileus

Ileus Clinical Trial

Official title:

Effect of Thoracic Epidural Analgesia on Bowel Function Recovery in Major Upper Abdominal Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02491385
• Other study ID #: 2014-12-129
• Status: Completed
• Phase: N/A
• First received: June 30, 2015
• Last updated: July 2, 2015
• Start date: April 2014
• Est. completion date: March 2015

Study information

• Verified date: July 2015
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists' (ASA) physical status?-?

Exclusion Criteria:

• ASA status of ?, or more

• Body mass index 30 kg.m2-1 or more

• Severe renal, hepatic, or neurologic diseases

• Opioid or systemic analgesic preoperatively

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ileus

Intervention

Procedure:
• thoracic epidural analgesia
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.

Drug:
• iv-PCA
iv-PCA setting was fentanyl 20 mcg/ml, bolus/lock out time/basal, 0.5 ml/15 min/0.5 ml.

Locations

Country	Name	City	State
Korea, Republic of	Samsung medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gas out time		from operation to post operative 10 days	No
Secondary	voiding time		from operation to post operative 10 days	No
Secondary	numeric rating scale for pain		from operation to post operative 3 days	No