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A Trial Comparing Transversus Abdominis Plane Catheter Versus Epidural After Esophagectomy

Primary Purpose

Esophageal Cancer, Pain, Postoperative

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Esophagectomy
Transversus abdominis plane catheter
Epidural
Sponsored by
Swedish Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring esophageal cancer, transversus abdominis plane catheter, epidural, pain, postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Swedish Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transversus abdominis plane catheter

epidural

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain scores
Pain scores on a scale of 0-10 will be collected from patients twice a day

Secondary Outcome Measures

Volume Resuscitation
Amount of fluids given to patient
Hypotension
Total episodes of hypotension

Full Information

First Posted
March 21, 2018
Last Updated
January 19, 2023
Sponsor
Swedish Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03570996
Brief Title
A Trial Comparing Transversus Abdominis Plane Catheter Versus Epidural After Esophagectomy
Official Title
A Randomized Controlled Trial Comparing Transversus Abdominis Plane Catheter Versus Epidural After Esophagectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
COVID 19
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swedish Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Pain, Postoperative
Keywords
esophageal cancer, transversus abdominis plane catheter, epidural, pain, postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Randomization into either transversus abdominis plane catheter (TAP) or epidural for patients undergoing esophagectomy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transversus abdominis plane catheter
Arm Type
Active Comparator
Arm Description
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.
Arm Title
epidural
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Esophagectomy
Intervention Description
Esophagectomy with minimally invasive approach of the chest including: 3 hole with R video-assisted thoracoscopic surgery (VATS), Ivor Lewis R VATS, Transhiatal
Intervention Type
Procedure
Intervention Name(s)
Transversus abdominis plane catheter
Other Intervention Name(s)
TAP catheter
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Epidural
Other Intervention Name(s)
TEP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain scores
Description
Pain scores on a scale of 0-10 will be collected from patients twice a day
Time Frame
Up to post-operative day 4
Secondary Outcome Measure Information:
Title
Volume Resuscitation
Description
Amount of fluids given to patient
Time Frame
Up to post-operative day 4
Title
Hypotension
Description
Total episodes of hypotension
Time Frame
Up to post-operative day 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian E Louie, MD
Organizational Affiliation
Swedish Cancer Institute and Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Trial Comparing Transversus Abdominis Plane Catheter Versus Epidural After Esophagectomy

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