A Trial Comparing Transversus Abdominis Plane Catheter Versus Epidural After Esophagectomy

Swedish Medical Center

Status: Terminated

Conditions: Esophageal Cancer; Pain, Postoperative

Treatments: Procedure: Transversus abdominis plane catheter; Procedure: Esophagectomy; Procedure: Epidural

Study type: Interventional

Funder types: Other

Identifiers

NCT03570996

STUDY2017000592

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

38 participants in 2 patient groups

Transversus abdominis plane catheter

Active Comparator group

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.

Treatment:

Procedure: Esophagectomy

Procedure: Transversus abdominis plane catheter

epidural

Active Comparator group

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.

Treatment:

Procedure: Epidural

Procedure: Esophagectomy