Postoperative Pain Management After Minimally Invasive Esophagectomy

NCT02042313 | Unknown Phase 4

• 1 other identifier: 20131015A
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Intraoperative hypotension ( > 30% decline in the preoperative systolic/diastolic blood pressure)

  during operation

Secondary Outcomes (1)

• NRS pain score

  postoperative day 0 to 4

Other Outcomes (1)

• Tidal volume

  postoperative day 1 to4

Study Arms (2)

Epidural

ACTIVE COMPARATOR

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

combined PVB TAP

EXPERIMENTAL

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

Interventions

continuous epidural infusion OTHER

Epidural

combined paravertebral infusion and single shot of TAP block OTHER

combined PVB TAP

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has a physical status between ASA I and III
• years of age
• Patient has signed an informed consent
• Without contraindication of GA, EA or PVB

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan, 11259, Taiwan

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Nai Liang Li, MD

CONTACT

886-2-28970011; lnl@kfsyscc.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 22, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2016
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

TW (1)