Postoperative Pain Management After Minimally Invasive Esophagectomy

Phase 4

• Conditions: Esophageal Cancer

• Registration Number: NCT02042313
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-01-18
• Study First Posted: 2014-01-22
• Study Start: 2014-02
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-15
• Last Update Posted: 2015-12-16
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intraoperative hypotension ( > 30% decline in the preoperative systolic/diastolic blood pressure)	during operation

Secondary Outcome Measures

Name	Time	Method
NRS pain score	postoperative day 0 to 4

Trial Locations

Locations (1)

Koo Foundation Sun Yat-Sen Cancer Center; 🇨🇳 Taipei, Taiwan