Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
ID05906134

Randomized Trial Comparing Intercostal Nerve Blocks, Cryo-ablation Plus Blocks, and Serratus Plane Catheter Plus Blocks After Minimally Invasive Esophagectomy

Led by Swedish Medical Center · Updated on 2025-07-23

30

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates pain control methods for patients undergoing minimally invasive esophagectomy, a surgery on the esophagus. The study compares three approaches: local intercostal nerve blocks alone, cryo-ablation combined with intercostal nerve blocks, and serratus plane catheter plus intercostal nerve blocks. It is a pilot randomized controlled trial designed to evaluate which method may better manage acute postoperative pain in these patients. Participants will be randomly assigned to one of three groups before surgery. One group receives local intercostal nerve blocks with a specific dose of bupivacaine and epinephrine. Another group receives cryo-ablation near the sympathetic chain followed by the same nerve blocks. The third group receives serratus plane catheter blocks plus intercostal nerve blocks, including a continuous infusion of ropivacaine and daily boluses of bupivacaine with epinephrine for five days after surgery. Additional pain control with thoracic epidural catheters may be provided if needed. During the hospital stay, participants are monitored for pain every 12 hours up to four days after surgery. After discharge, follow-up continues for one year at a thoracic surgery clinic to collect further data. The main outcome measured is the change in postoperative pain from before surgery through the first four postoperative days. This study aims to provide detailed information on pain control effectiveness and safety during and after minimally invasive esophagectomy.

CONDITIONS

Brief Title

Minimally Invasive Esophagectomy Pain Control Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Undergoing esophagectomy with a planned minimally invasive thoracic approach
  • Surgical approaches include 3-hole with video-assisted thoracoscopic surgery (VATS) or Ivor Lewis VATS
  • Able to provide informed consent
  • English speaking
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Unable to consent to participate
  • Additional surgical procedures planned during the operation
  • History of previous thoracic surgery
  • Daily use of narcotics for chronic pain
  • Non-English speaking
  • Contraindications to neuraxial anesthesia such as ongoing or planned anticoagulation, spinal cord stimulators, or anatomical issues preventing epidural placement

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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3
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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Hospital stay until discharge

Participants undergo minimally invasive esophagectomy and receive one of three pain control interventions on the day of surgery: local intercostal nerve block, cryo-ablation plus intercostal nerve block, or serratus plane catheter plus intercostal nerve block. Pain management is monitored throughout the hospital stay until discharge.

Daily visits during hospital stay

Post-operative Follow-up

Duration - Up to 1 year post-operatively

Participants attend follow-up visits at the Swedish Thoracic Surgery Clinic for pain and recovery assessments up to 1 year after surgery.

Multiple follow-up visits over 1 year

Trial Site Locations

Total: 1 location

1

Swedish Cancer Institute

Seattle, Washington, United States, 98104

Actively Recruiting

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Research Team

B

Brian Louie, M.D.

M

Meagan Ivy, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Frequently Asked Questions

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