Thoracic Epidural for Postoperative Ileus

NCT ID: NCT02491385

Last Updated: 2015-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-03-31

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.

Conditions

Ileus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TEA

thoracic epidural analgesia group

Group Type: EXPERIMENTAL

thoracic epidural analgesia

Intervention Type: PROCEDURE

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

intravenous patient controlled analgesia group

Group Type: ACTIVE_COMPARATOR

iv-PCA

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: PROCEDURE

iv-PCA

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Hyun Joo Ahn

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hyun Joo Ahn, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

Locations

Samsung medical center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2014-12-129

Identifier Type: -

Identifier Source: org_study_id