A Trial Comparing Transversus Abdominis Plane Catheter Versus Epidural After Esophagectomy

A Randomized Controlled Trial Comparing Transversus Abdominis Plane Catheter Versus Epidural After Esophagectomy

A randomized trial comparing perioperative outcomes between bilateral transversus abdominis plane TAP catheters with patient controlled analgesia (PCA) to epidural for esophagectomy patients with a VATS chest approach. Further objectives are to determine pain requirements between multiple modalities of pain control and compare the subsequent sequelae of narcotic use and blood pressure control and to compare complications such as anastomotic leak, atrial fibrillation and perioperative morbidity and mortality between the two groups.

Study Overview

• Status: Terminated
• Conditions: Pain, Postoperative; Esophageal Cancer
• Intervention / Treatment: Procedure: Esophagectomy; Procedure: Transversus abdominis plane catheter; Procedure: Epidural

Detailed Description

Epidural analgesia is considered the 'gold standard' for post-operative analgesia following open esophagectomy. Epidurals have been shown to reduce post-operative pulmonary morbidity and mortality. However, epidurals are often associated with sympathetic blockade that creates hypotension and could therefore adversely affect the conduit. Pain management techniques that use peripheral nerve blockade are becoming more prevalent, reducing the need for an epidural. Transversus abdominis plane (TAP) catheters have been used in colorectal and abdominal surgery showing equivocal pain scores to epidurals. With the minimally invasive chest approach, the analgesia coverage focuses on the abdominal incision where both epidurals and TAPs are considered standard of care.

The investigators have completed a retrospective study in preparation for a randomized control trial. The investigators previous retrospective study found that TAP blocks/catheters are a reasonable alternative to epidurals, providing adequate pain coverage for abdominal incisions. The study found no statistical difference in pain scores between the two groups. The TAP group had a lower prevalence of hypotension and lower crystalloid resuscitation needs. Pulmonary complications were similar between the two groups. This retrospective review showed that TAP blocks are a reasonable alternative to epidurals and may reduce episodes of hypotension. The investigators aim is to now expand this study to a randomized control trial.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All adult individuals who undergo an esophagectomy with a minimally invasive approach of the chest at Swedish Medical Center-First Hill. These approaches include:
• 3 hole with R video-assisted thoracoscopic surgery (VATS)
• Ivor Lewis R VATS
• Transhiatal

Exclusion Criteria:

• Age <18
• Unable to consent
• Additional surgical procedures planned
• Patient with chronic pain on a daily regimen of narcotics
• Patients who remain intubated greater than 24 hours post operatively
• Non-English speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transversus abdominis plane catheter; Transversus abdominis plane catheter (TAP) for pain control in esophagectomy operations. TAP group will have bilateral subcostal TAP catheters and single shot bilateral rectus sheath blocks placed at the end of the surgery, prior to emergence. Bilateral subcostal TAP catheters will be bolused with 20ml of .2% ropivacaine on each side and then infused with .2% ropivacaine at 10ml/ hr for 75 hours each. Rectus sheath blocks will be bilateral bolus 20ml of .2% ropivacaine.	Procedure: Esophagectomy; Esophagectomy with minimally invasive approach of the chest including: 3 hole with R video-assisted thoracoscopic surgery (VATS), Ivor Lewis R VATS, Transhiatal; Procedure: Transversus abdominis plane catheter; TAP group will have bilateral subcostal TAP catheters and single shot bilateral rectus sheath blocks placed at the end of the surgery, prior to emergence. Bilateral subcostal TAP catheters will be bolused with 20ml of .2% ropivacaine on each side and then infused with .2% ropivacaine at 10ml/ hr for 75 hours each. Rectus sheath blocks will be bilateral bolus 20ml of .2% ropivacaine; Other Names: TAP catheter
Active Comparator: epidural; Epidural pain control for pain control in esophagectomy operation. Patients randomize the TEP group will have bilateral TEP placed at T8-9 +/- one level based on patient anatomy. TEP will be bolused with 5ml of 1.5% lidocaine with epinephrine and then started on infusion of .0625% bupivacaine plus 4 mcg/ml fentanyl plus 2 mcg/ ml epinephrine at 6ml/hr with a range of 6-12 ml/hr, titrating to optimize patient comfort. Epidurals are placed before surgery start time.	Procedure: Esophagectomy; Esophagectomy with minimally invasive approach of the chest including: 3 hole with R video-assisted thoracoscopic surgery (VATS), Ivor Lewis R VATS, Transhiatal; Procedure: Epidural; Patients randomize the TEP group will have bilateral TEP placed at T8-9 +/- one level based on patient anatomy. TEP will be bolused with 5ml of 1.5% lidocaine with epinephrine and then started on infusion of .0625% bupivacaine plus 4 mcg/ml fentanyl plus 2 mcg/ ml epinephrine at 6ml/hr with a range of 6-12 ml/hr, titrating to optimize patient comfort. Epidurals are placed before surgery start time.; Other Names: TEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	Pain scores on a scale of 0-10 will be collected from patients twice a day	Up to post-operative day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume Resuscitation	Amount of fluids given to patient	Up to post-operative day 4
Hypotension	Total episodes of hypotension	Up to post-operative day 4

Collaborators and Investigators

• Sponsor: Swedish Medical Center
• Investigators: Principal Investigator: Brian E Louie, MD, Swedish Cancer Institute and Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: June 25, 2018
• First Posted (Actual): June 27, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: esophageal cancer; epidural; pain, postoperative; transversus abdominis plane catheter
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Pain; Neurologic Manifestations; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Pain, Postoperative; Esophageal Neoplasms
• Other Study ID Numbers: STUDY2017000592

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No