Postoperative Pain Management After Minimally Invasive Esophagectomy

NCT ID: NCT02042313

Last Updated: 2015-12-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28

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.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

continuous epidural infusion

Intervention Type: OTHER

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.

Group Type: EXPERIMENTAL

combined paravertebral infusion and single shot of TAP block

Intervention Type: OTHER

Interventions

continuous epidural infusion

Intervention Type: OTHER

combined paravertebral infusion and single shot of TAP block

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Nai Liang Li

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Nai Liang Li, MD

Role: CONTACT

Phone: 886-2-28970011

Email: lnl@kfsyscc.org

Facility Contacts

Nai Liang Li

Role: primary

Other Identifiers

20131015A

Identifier Type: -

Identifier Source: org_study_id