NCT05906134

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
9mo left

Started Apr 2022

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Apr 2022Feb 2027

Study Start

First participant enrolled

April 26, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Expected
Last Updated

July 23, 2025

Status Verified

February 1, 2025

Enrollment Period

3.9 years

First QC Date

January 30, 2023

Last Update Submit

July 17, 2025

Conditions

Postoperative Pain, AcutePostoperative Complications

Outcome Measures

Primary Outcomes (11)

  • Post Operative Pain Change Over Time

    Compare post-operative pain score changes over time between intercostal nerve blocks, cryo-analgesia, and serratus plane catheters in patients undergoing minimally invasive esophagectomy. Patients will be asked specifically about thoracic/chest pain and asked to rate this pain on a Likert pain scale of 0-10, 0 being no pain and 10 being the worst pain they can imagine.

    Baseline (prior to OR) to every 12 hours postoperatively thru Post Operative Day 4.

  • Post Operative Pain

    Compare single timepoint post-operative pain scores between intercostal nerve blocks, cryo-analgesia, and serratus plane catheters in patients undergoing minimally invasive esophagectomy. Patients will be asked specifically about thoracic/chest pain and asked to rate this pain on a Likert pain scale of 0-10, 0 being no pain and 10 being the worst pain they can imagine.

    Baseline (Prior to OR)

  • Post Operative Pain

    Compare single timepoint post-operative pain scores between intercostal nerve blocks, cryo-analgesia, and serratus plane catheters in patients undergoing minimally invasive esophagectomy. Patients will be asked specifically about thoracic/chest pain and asked to rate this pain on a Likert pain scale of 0-10, 0 being no pain and 10 being the worst pain they can imagine.

    Post-Op Time 0

  • Post Operative Pain Day 1 (AM)

    Compare single timepoint post-operative pain scores between intercostal nerve blocks, cryo-analgesia, and serratus plane catheters in patients undergoing minimally invasive esophagectomy. Patients will be asked specifically about thoracic/chest pain and asked to rate this pain on a Likert pain scale of 0-10, 0 being no pain and 10 being the worst pain they can imagine.

    Post Operative Day 1 (AM)

  • Post Operative Pain Day 1 (PM)

    Compare single timepoint post-operative pain scores between intercostal nerve blocks, cryo-analgesia, and serratus plane catheters in patients undergoing minimally invasive esophagectomy. Patients will be asked specifically about thoracic/chest pain and asked to rate this pain on a Likert pain scale of 0-10, 0 being no pain and 10 being the worst pain they can imagine.

    Post Operative Day 1 (PM)

  • Post Operative Pain Day 2 (AM)

    Compare single timepoint post-operative pain scores between intercostal nerve blocks, cryo-analgesia, and serratus plane catheters in patients undergoing minimally invasive esophagectomy. Patients will be asked specifically about thoracic/chest pain and asked to rate this pain on a Likert pain scale of 0-10, 0 being no pain and 10 being the worst pain they can imagine.

    Post Operative Day 2 (AM)

  • Post Operative Pain Day 2 (PM)

    Compare single timepoint post-operative pain scores between intercostal nerve blocks, cryo-analgesia, and serratus plane catheters in patients undergoing minimally invasive esophagectomy. Patients will be asked specifically about thoracic/chest pain and asked to rate this pain on a Likert pain scale of 0-10, 0 being no pain and 10 being the worst pain they can imagine.

    Post Operative Day 2 (PM)

  • Post Operative Pain Day 3 (AM)

    Compare single timepoint post-operative pain scores between intercostal nerve blocks, cryo-analgesia, and serratus plane catheters in patients undergoing minimally invasive esophagectomy. Patients will be asked specifically about thoracic/chest pain and asked to rate this pain on a Likert pain scale of 0-10, 0 being no pain and 10 being the worst pain they can imagine.

    Post Operative Day 3 (AM)

  • Post Operative Pain Day 3 (PM)

    Compare single timepoint post-operative pain scores between intercostal nerve blocks, cryo-analgesia, and serratus plane catheters in patients undergoing minimally invasive esophagectomy. Patients will be asked specifically about thoracic/chest pain and asked to rate this pain on a Likert pain scale of 0-10, 0 being no pain and 10 being the worst pain they can imagine.

    Post Operative Day 3 (PM)

  • Post Operative Pain Day 4 (AM)

    Compare single timepoint post-operative pain scores between intercostal nerve blocks, cryo-analgesia, and serratus plane catheters in patients undergoing minimally invasive esophagectomy. Patients will be asked specifically about thoracic/chest pain and asked to rate this pain on a Likert pain scale of 0-10, 0 being no pain and 10 being the worst pain they can imagine.

    Post Operative Day 4 (AM)

  • Post Operative Pain Day 4 (PM)

    Compare single timepoint post-operative pain scores between intercostal nerve blocks, cryo-analgesia, and serratus plane catheters in patients undergoing minimally invasive esophagectomy. Patients will be asked specifically about thoracic/chest pain and asked to rate this pain on a Likert pain scale of 0-10, 0 being no pain and 10 being the worst pain they can imagine.

    Post Operative Day 4 (PM)

Study Arms (3)

local intercostal nerve block

ACTIVE COMPARATOR

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.

Procedure: Local intercostal nerve blockProcedure: Thoracic epidural catheter

cryo-ablation plus intercostal nerve block

ACTIVE COMPARATOR

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.

Procedure: Cryo-analgesia and intercostal nerve blockProcedure: Thoracic epidural catheter

serratus plane catheter plus intercostal nerve block

ACTIVE COMPARATOR

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.

Procedure: Serratus plane catheter blocks and intercostal nerve blocksProcedure: Thoracic epidural catheter

Interventions

Local intercostal nerve blockPROCEDURE

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.

local intercostal nerve block
Cryo-analgesia and intercostal nerve blockPROCEDURE

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.

Also known as: Cryo-ablation
cryo-ablation plus intercostal nerve block
Serratus plane catheter blocks and intercostal nerve blocksPROCEDURE

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.

serratus plane catheter plus intercostal nerve block
Thoracic epidural catheterPROCEDURE

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.

cryo-ablation plus intercostal nerve blocklocal intercostal nerve blockserratus plane catheter plus intercostal nerve block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • hole with R video-assisted thoracoscopic surgery (VATS)
  • Ivor Lewis R VATS

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swedish Cancer Institute

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativePostoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Brian Louie, M.D.

    Swedish Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Louie, M.D.

CONTACT

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

Meagan Ivy, M.D.

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The randomization method will be sealed opaque envelopes with computer generated numbers inside that will have been created at the start of the study. The envelopes will be kept in the Thoracic Surgery clinic by the research coordinator. At the time of randomization, the envelope will be picked from random for each patient designating which group they will be assigned to. The anesthesia team, the thoracic surgeon performing the surgery, and the thoracic surgery clinical fellows for the study will be made aware of what arm the subject is part of for preoperative planning.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2023

First Posted

June 15, 2023

Study Start

April 26, 2022

Primary Completion

April 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

July 23, 2025

Record last verified: 2025-02

Locations

US(1)