A Trial Comparing Transversus Abdominis Plane Catheter Versus Epidural After Esophagectomy

NCT03570996 | Terminated

• 1 other identifier: STUDY2017000592
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer; Pain, Postoperative

Keywords

esophageal cancer; transversus abdominis plane catheter; epidural; pain, postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Volume Resuscitation

  Up to post-operative day 4

• Hypotension

  Up to post-operative day 4

Study Arms (2)

Transversus abdominis plane catheter

ACTIVE COMPARATOR

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; Procedure: Transversus abdominis plane catheter

epidural

ACTIVE COMPARATOR

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; Procedure: Epidural

Interventions

Esophagectomy PROCEDURE

Esophagectomy with minimally invasive approach of the chest including: 3 hole with R video-assisted thoracoscopic surgery (VATS), Ivor Lewis R VATS, Transhiatal

Transversus abdominis plane catheter; epidural

Transversus abdominis plane catheter PROCEDURE

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

Also known as: TAP catheter

Transversus abdominis plane catheter

Epidural PROCEDURE

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.

Also known as: TEP

epidural

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swedish Medical Center: lead

Study Sites (1)

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Pain, Postoperative

Interventions

Esophagectomy; Injections, Epidural; tetraethylpyrazine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Brian E Louie, MD

  Swedish Cancer Institute and Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization into either transversus abdominis plane catheter (TAP) or epidural for patients undergoing esophagectomy

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: June 27, 2018
• Study Start: January 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)