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Clinical Trials/NCT03570996
NCT03570996
Terminated
Not Applicable

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

Swedish Medical Center1 site in 1 country38 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophageal Cancer
Sponsor
Swedish Medical Center
Enrollment
38
Locations
1
Primary Endpoint
Pain scores
Status
Terminated
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
March 1, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

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

  • 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

Outcomes

Primary Outcomes

Pain scores

Time Frame: Up to post-operative day 4

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

Secondary Outcomes

  • Volume Resuscitation(Up to post-operative day 4)
  • Hypotension(Up to post-operative day 4)

Study Sites (1)

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