Clinical trial NCT03570996: 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
Overall status: TERMINATED
Phase: NA
Conditions: Esophageal Cancer
Pain, Postoperative
Keywords: esophageal cancer
transversus abdominis plane catheter
epidural
pain, postoperative
Lead sponsor: Swedish Medical Center
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Randomization into either transversus abdominis plane catheter (TAP) or epidural for patients undergoing esophagectomy
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain scores
timeFrame: Up to post-operative day 4
Secondary outcomes:
measure: Volume Resuscitation
timeFrame: Up to post-operative day 4
measure: Hypotension
timeFrame: Up to post-operative day 4
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
Study officials:
affiliation: Swedish Cancer Institute and Medical Center
name: Brian E Louie, MD
role: PRINCIPAL_INVESTIGATOR
References: