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Postoperative Pain Management After Minimally Invasive Esophagectomy
Conditions
Esophageal Cancer
Conditions: official terms
Esophageal Neoplasms
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: continuous epidural infusion
Type: Other
Name: combined paravertebral infusion and single shot of TAP block
Type: Other
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 20 Years
Gender: Both
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
- 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
Location
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan
Status: Not yet recruiting
Contact: Nai Liang Li - 886-2-28970011
Start Date
February 2014
Sponsors
Sun Yat-sen University
Source
Sun Yat-sen University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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