Back to resultsMinimally Invasive Esophagectomy Pain Control Trial
Primary Purpose
Postoperative Pain, Acute, Postoperative Complications
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Thoracic epidural catheter
Local intercostal nerve block
Cryo-analgesia and intercostal nerve block
Serratus plane catheter blocks and intercostal nerve blocks
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain, Acute
Eligibility Criteria
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)
Sites / Locations
- Swedish Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
local intercostal nerve block
cryo-ablation plus intercostal nerve block
serratus plane catheter plus intercostal nerve block
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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 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 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 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 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 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 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 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 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 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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05906134
Brief Title
Minimally Invasive Esophagectomy Pain Control Trial
Official Title
A Randomized Controlled Trial Comparing Local Intercostal Nerve Blocks, Cryo-ablation Plus Intercostal Nerve Blocks, and Serratus Plane Catheter Plus Intercostal Nerve Blocks After Minimally Invasive Esophagectomy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2022 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swedish Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Pilot study planned to consent 30 patients in total with a projected study timeline of 2-3 years for completion. Participants will be enrolled in the study and randomized in their preoperative clinic visit. On the day of surgery, they will receive the intervention they were randomized to. 10 patients will be randomized to the intercostal block group, 10 patients will be randomized to the cryo-ablation plus intercostal block group, and 10 patients will be randomized to the serratus plane catheter plus intercostal block group. They will be followed throughout their hospital stay until discharge for data collection purposes. Once the patient is discharged from the hospital, post-operative follow-up in the Swedish Thoracic Surgery Clinic will be collected up to 1 year post-operatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Acute, Postoperative Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
local intercostal nerve block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
cryo-ablation plus intercostal nerve block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
serratus plane catheter plus intercostal nerve block
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Thoracic epidural catheter
Intervention Description
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 be added as an adjunct to the study arm and will be noted in the data set. This will likely consist of a thoracic epidural catheter.
Intervention Type
Procedure
Intervention Name(s)
Local intercostal nerve block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cryo-analgesia and intercostal nerve block
Other Intervention Name(s)
Cryo-ablation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Serratus plane catheter blocks and intercostal nerve blocks
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post Operative Pain Change Over Time
Description
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.
Time Frame
Baseline (prior to OR) to every 12 hours postoperatively thru Post Operative Day 4.
Title
Post Operative Pain
Description
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.
Time Frame
Baseline (Prior to OR)
Title
Post Operative Pain
Description
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.
Time Frame
Post-Op Time 0
Title
Post Operative Pain Day 1 (AM)
Description
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.
Time Frame
Post Operative Day 1 (AM)
Title
Post Operative Pain Day 1 (PM)
Description
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.
Time Frame
Post Operative Day 1 (PM)
Title
Post Operative Pain Day 2 (AM)
Description
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.
Time Frame
Post Operative Day 2 (AM)
Title
Post Operative Pain Day 2 (PM)
Description
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.
Time Frame
Post Operative Day 2 (PM)
Title
Post Operative Pain Day 3 (AM)
Description
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.
Time Frame
Post Operative Day 3 (AM)
Title
Post Operative Pain Day 3 (PM)
Description
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.
Time Frame
Post Operative Day 3 (PM)
Title
Post Operative Pain Day 4 (AM)
Description
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.
Time Frame
Post Operative Day 4 (AM)
Title
Post Operative Pain Day 4 (PM)
Description
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.
Time Frame
Post Operative Day 4 (PM)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Louie, M.D.
Phone
(206) 215-6800
Email
brian.louie@swedish.org
First Name & Middle Initial & Last Name or Official Title & Degree
Meagan Ivy, M.D.
Phone
(206) 215-6800
Email
megan.ivy@swedish.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Louie, M.D.
Organizational Affiliation
Swedish Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Louie, M.D.
Phone
206-215-6800
Email
brian.louie@swedish.org
First Name & Middle Initial & Last Name & Degree
Meagan Ivy, M.D.
Phone
206-215-6800
Email
megan.ivy@swedish.org
12. IPD Sharing Statement
Learn more about this trial
Minimally Invasive Esophagectomy Pain Control Trial
We'll reach out to this number within 24 hrs