Trials / Completed
CompletedNCT02491385
Thoracic Epidural for Postoperative Ileus
Effect of Thoracic Epidural Analgesia on Bowel Function Recovery in Major Upper Abdominal Surgeries
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Samsung Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2015-03-01
- Completion
- 2015-03-01
- First posted
- 2015-07-08
- Last updated
- 2015-07-08
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02491385. Inclusion in this directory is not an endorsement.