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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural | Active Comparator | 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. |
|
| combined PVB TAP | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous epidural infusion | Other |
| ||
| combined paravertebral infusion and single shot of TAP block |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative hypotension ( > 30% decline in the preoperative systolic/diastolic blood pressure) | during operation |
| Measure | Description | Time Frame |
|---|---|---|
| NRS pain score | postoperative day 0 to 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Tidal volume | postoperative day 1 to4 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nai Liang Li, MD | Contact | 886-2-28970011 | 1666 | lnl@kfsyscc.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Koo Foundation Sun Yat-Sen Cancer Center | Recruiting | Taipei | Taiwan | 11259 | Taiwan |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Other |
|
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |