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Trial Title:
Postoperative Pain Management After Minimally Invasive Esophagectomy
NCT ID:
NCT02042313
Condition:
Esophageal Cancer
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
continuous epidural infusion
Arm group label:
Epidural
Intervention type:
Other
Intervention name:
combined paravertebral infusion and single shot of TAP block
Arm group label:
combined PVB TAP
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:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Koo Foundation Sun Yat-Sen Cancer Center
Address:
City:
Taipei
Zip:
11259
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Nai Liang Li
Phone:
886-2-28970011
Phone ext:
1666
Start date:
February 2014
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02042313
