An interventional study of thoracic epidural analgesia and iv-PCA in Ileus, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-08.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment
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.
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.
124 studies on the registry are indexed under Ileus; 12 are open to participants now.
This study's enrollment of 28 is below the median of 97 across 106 interventional studies indexed under Ileus.
Browse Ileus studies →Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Exclusion Criteria:
thoracic epidural analgesia group
Procedure: thoracic epidural analgesia
intravenous patient controlled analgesia group
Drug: iv-PCA
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 setting was fentanyl 20 mcg/ml, bolus/lock out time/basal, 0.5 ml/15 min/0.5 ml.
gas out time
Time frame: from operation to post operative 10 days
voiding time
Time frame: from operation to post operative 10 days
numeric rating scale for pain
Time frame: from operation to post operative 3 days
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Samsung Medical Center