Postoperative Pain Management After Minimally Invasive Esophagectomy

Study Overview
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Brief Summary
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Esophagectomy is a major surgical procedure often associated with significant morbidity and mortality and significant level of postoperative pain. In contrast to open esophagectomy where epidural pain control has been considered as a gold standard and could be crucial in affecting outcome the analgesic scheme for minimally invasive esophagectomy (MIE) is yet to be established. We would like to compare continuous epidural analgesia and continuous paravertebral block combined with single shot subcostal transversus abdominis plane (TAP) block in the analgesic effects, levels of cytokines, and postoperative complications in patients receiving MIE.

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Other: continuous epidural infusion
* Other: combined paravertebral infusion and single shot of TAP block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has a physical status between ASA I and III 20 - 75 years of age Patient has signed an informed consent Without contraindication of GA, EA or PVB Exclusion Criteria: ASA > III Inability to provide informed consent Bleeding disorders Being pregnant Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs), Allergy to amide-type local anesthetics or NSAIDs Infection at the thoracic paravertebral injection site Severe spine or chest wall deformity Patients with major psychosis or drug and alcohol abuse Patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease Patients with physical disability that precludes complete cooperation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural<br>Epidural catheters will be applied at the T6-8 level prior to the induction. 6 ml of 2% xylocaine with 1 in 200,000 epinephrine administered before surgery. During the surgery, 2% xylocaine with 1 in 200,000 epinephrine infusion will be administered at a rate of 2-10 ml/hour adjusted according to patient's blood pressure. After surgery, 0.125% levobupivacaine with 2.5μg fentanyl and 1 in 400,000 epinephrine will be given at a rate of 0.10-0.15 ml kg-1 h-1 (0.5 h lock and 2 ml bolus) through a patient-controlled infusion pump. | Other: continuous epidural infusion<br> <br> |
| Experimental: combined PVB TAP<br>Paravertebral catheterization into the paravertebral region ipsilateral to the VATS incision as described by Murata at the level of T7-8 will be performed. 10 ml of 2% xylocaine with 1 in 200,000 epinephrine to initiate analgesia. During the surgery, 2% xylocaine with 1 in 200,000 epinephrine infusion will be administered at a rate of 2-10 ml/hour adjusted according to patient's blood pressure. After the surgery, 0.125% levobupivacaine with 2.5μg fentanyl and 1 in 400,000 epinephrine will be administered at the rate of 0.10-0.15 ml kg-1 h-1 (0.5 h lock and 2 ml bolus) through a patient-controlled infusion pump. Ultrasound-guided (USG) subcostal TAP block will be performed at the end of surgery. Fifteen milliliters of 0.5% levobupivacaine with 1 in 400,000 epinephrine will be injected in incremental doses on each side of the abdomen. | Other: combined paravertebral infusion and single shot of TAP block<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative hypotension ( > 30% decline in the preoperative systolic/diastolic blood pressure) |  | during operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS pain score |  | postoperative day 0 to 4 |