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Postoperative Pain Management After Minimally Invasive Esophagectomy (MIEPVBEA)

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ClinicalTrials.gov Identifier: NCT02042313
Recruitment Status : Unknown
Verified December 2015 by Nai Liang Li, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : January 22, 2014
Last Update Posted : December 16, 2015
Sponsor:
Information provided by (Responsible Party):
Nai Liang Li, Sun Yat-sen University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Other: continuous epidural infusion Other: combined paravertebral infusion and single shot of TAP block Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2014
Estimated Primary Completion Date : December 2016

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Arm Intervention/treatment
Active Comparator: Epidural
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
Experimental: combined PVB TAP

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



Primary Outcome Measures :
  1. Intraoperative hypotension ( > 30% decline in the preoperative systolic/diastolic blood pressure) [ Time Frame: during operation ]

Secondary Outcome Measures :
  1. NRS pain score [ Time Frame: postoperative day 0 to 4 ]

Other Outcome Measures:
  1. Tidal volume [ Time Frame: postoperative day 1 to4 ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02042313


Contacts
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Contact: Nai Liang Li, MD 886-2-28970011 ext 1666 lnl@kfsyscc.org

Locations
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Taiwan
Koo Foundation Sun Yat-Sen Cancer Center Recruiting
Taipei, Taiwan, 11259
Contact: Nai Liang Li    886-2-28970011 ext 1666      
Sponsors and Collaborators
Sun Yat-sen University

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Responsible Party: Nai Liang Li, MD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02042313     History of Changes
Other Study ID Numbers: 20131015A
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015