Recruiting

Phase 1

Phase 2

EsophagectomyMinimally Invasive Esophagectomy Pain Control Trial

Sponsor:

Swedish Medical Center

Code:

NCT05906134

Conditions

Postoperative Pain, Acute

Postoperative Complications

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Local intercostal nerve block

Cryo-analgesia and intercostal nerve block

Serratus plane catheter blocks and intercostal nerve blocks

Thoracic epidural catheter

Study Details

Brief summary:

A pilot randomized controlled trial comparing intercostal nerve blocks, cryo-ablation plus intercostal nerve blocks, and serratus plane catheter plus intercostal nerve blocks in patients undergoing esophagectomies with minimally invasive thoracic approaches.

Conditions

Postoperative Pain, Acute

Postoperative Complications

Study ID

NCT05906134

Start date

Apr 26, 2022

Status verified date

Feb, 2025

Completion date

Feb, 2027

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

All adult individuals who undergo an esophagectomy with an intended 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

Exclusion Criteria:

Age <18
Unable to consent
Additional surgical procedures planned
Patients with previous thoracic surgery
Patient with chronic pain on a daily regimen of narcotics
Non-English speaking
Contraindications to neuraxial anesthesia (ongoing anticoagulation, anticipated post-operative therapeutic anticoagulation, spinal cord stimulators, anatomic abnormalities preventing epidural placement)

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: local intercostal nerve block

Patients receiving intercostal blocks will receive a total of 1.0 cc/kg of 0.25% Bupivacaine + epinephrine. This will be divided into two-thirds allocated for use in the chest/intercostal block and one-third allocated for use in the abdomen.

active comparator: cryo-ablation plus intercostal nerve block

Patients receiving cryo-analgesia and intercostal blocks, the patient will receive cryo-ablation prior to the intercostal block. The cryo-ablation will occur 2 cm from the sympathetic chain 2 intercostal spaces above and 2 intercostal spaces below the access incision. The patient will also receive a total of 1.0 cc/kg of 0.25% Bupivacaine + epinephrine. This will be divided into two-thirds allocated for use in the chest/intercostal block and one-third allocated for use in the abdomen.

active comparator: serratus plane catheter plus intercostal nerve block

Patients receiving serratus plane catheter blocks and intercostal nerve blocks, a total of 1.0 cc/kg of 0.25% Bupivacaine + epinephrine will be administered. A total of 20 cc of the weight-based calculation will be reserved for the serratus plane catheter. The remaining local anesthetic will be divided into two-thirds for the chest and one-third for the abdomen. Patients with serratus plane catheters will have an ongoing infusion of 0.2% ropivacaine at 8 ml per hour. The serratus plane catheters will also receive a bolus of 20 ml of 0.25% bupivacaine with epinephrine on Post Operative Day (POD) #1, 2, 3, 4, and 5 by the pain service.

Interventions

Local intercostal nerve block

Cryo-analgesia and intercostal nerve block

The cryo-ablation will occur 2 cm from the sympathetic chain 2 intercostal spaces above and 2 intercostal spaces below the access incision. The patient will also receive a total of 1.2 cc/kg of 0.25% Bupivacaine + epinephrine. This will be divided into two-thirds allocated for use in the chest/intercostal block and one-third allocated for use in the abdomen.

Serratus plane catheter blocks and intercostal nerve blocks

A total of 1.2 cc/kg of 0.25% Bupivacaine + epinephrine will be administered. A total of 20 cc of the weight-based calculation will be reserved for the serratus plane catheter. The remaining local anesthetic will be divided into two-thirds for the chest and one-third for the abdomen. Patients with serratus plane catheters will have an ongoing infusion of 0.2% ropivacaine at 8 ml per hour. The serratus plane catheters will also receive a bolus of 20 ml of 0.25% bupivacaine with epinephrine on POD #1, 2, 3, 4, and 5 by the pain service.

Thoracic epidural catheter

The pain service and thoracic surgery attending physician will assess if the patient's pain is not well-controlled using the pain modality they are randomized to. If additional pain control is needed, this will likely consist of a thoracic epidural catheter.

Any additional pain control will be added as an adjunct to the study arm and will be noted in the data set.

Primary outcome measure

Post Operative Pain Change Over Time [ Time Frame: Baseline (prior to OR) to every 12 hours postoperatively thru Post Operative Day 4. ]
Post Operative Pain [ Time Frame: Baseline (Prior to OR) ]
Post Operative Pain [ Time Frame: Post-Op Time 0 ]
Post Operative Pain Day 1 (AM) [ Time Frame: Post Operative Day 1 (AM) ]
Post Operative Pain Day 1 (PM) [ Time Frame: Post Operative Day 1 (PM) ]
Post Operative Pain Day 2 (AM) [ Time Frame: Post Operative Day 2 (AM) ]
Post Operative Pain Day 2 (PM) [ Time Frame: Post Operative Day 2 (PM) ]
Post Operative Pain Day 3 (AM) [ Time Frame: Post Operative Day 3 (AM) ]
Post Operative Pain Day 3 (PM) [ Time Frame: Post Operative Day 3 (PM) ]
Post Operative Pain Day 4 (AM) [ Time Frame: Post Operative Day 4 (AM) ]
Post Operative Pain Day 4 (PM) [ Time Frame: Post Operative Day 4 (PM) ]

Central Contacts and Locations

Central contacts

Brian Louie, M.D.

(206) 215-6800 brian.louie@swedish.org

Meagan Ivy, M.D.

(206) 215-6800 megan.ivy@swedish.org

Locations

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104

Contacts

Brian Louie, M.D.

206-215-6800 brian.louie@swedish.org

Meagan Ivy, M.D.

206-215-6800 megan.ivy@swedish.org

More Information

Sponsor

Swedish Medical Center

Last update posted

Jul 23, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Swedish Medical Center on 2025-07-23.