Postoperative Pain Management After Minimally Invasive Esophagectomy (MIEPVBEA)

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.

Study Overview

• Status: Unknown
• Conditions: Esophageal Cancer
• Intervention / Treatment: Other: continuous epidural infusion; Other: combined paravertebral infusion and single shot of TAP block

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11259
    • Recruiting
    • Koo Foundation Sun Yat-Sen Cancer Center
    • Contact: Nai Liang Li; Phone Number: 1666 886-2-28970011

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intraoperative hypotension ( > 30% decline in the preoperative systolic/diastolic blood pressure)	during operation

Secondary Outcome Measures

Outcome Measure	Time Frame
NRS pain score	postoperative day 0 to 4

Other Outcome Measures

Outcome Measure	Time Frame
Tidal volume	postoperative day 1 to4

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: January 15, 2014
• First Submitted That Met QC Criteria: January 18, 2014
• First Posted (Estimate): January 22, 2014

Study Record Updates

• Last Update Posted (Estimate): December 16, 2015
• Last Update Submitted That Met QC Criteria: December 15, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 20131015A