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Pain Control Methods for Postoperative Esophagectomy Pain
Phase 1 & 2
Recruiting
Led By Brian Louie, M.D.
Research Sponsored by Swedish Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (prior to or) to every 12 hours postoperatively thru post operative day 4.
Awards & highlights
Study Summary
This trial tests how well 3 treatments reduce pain after an esophageal surgery.
Who is the study for?
This trial is for adults who are having a minimally invasive esophagectomy at Swedish Medical Center-First Hill. Candidates should be undergoing specific surgical approaches and must be able to consent. It's not for those under 18, on daily narcotics for chronic pain, with past thoracic surgery, non-English speakers, or with conditions that rule out epidural anesthesia.Check my eligibility
What is being tested?
The study compares different pain control methods after minimally invasive esophagectomies: intercostal nerve blocks alone, cryo-ablation plus nerve blocks, and serratus plane catheter plus nerve blocks. Patients will be randomly assigned to one of these treatment groups.See study design
What are the potential side effects?
Potential side effects may include discomfort at the block site, infection risk from catheters or injections used in the procedures, possible allergic reactions to anesthetics used during the blocks, and varying degrees of pain relief effectiveness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having a minimally invasive esophagectomy at Swedish Medical Center-First Hill.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (prior to or) to every 12 hours postoperatively thru post operative day 4.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (prior to or) to every 12 hours postoperatively thru post operative day 4.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post Operative Pain
Post Operative Pain Change Over Time
Post Operative Pain Day 1 (AM)
+7 moreTrial Design
3Treatment groups
Active Control
Group I: local intercostal nerve blockActive Control2 Interventions
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.
Group II: cryo-ablation plus intercostal nerve blockActive Control2 Interventions
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.
Group III: serratus plane catheter plus intercostal nerve blockActive Control2 Interventions
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.
Find a Location
Who is running the clinical trial?
Swedish Medical CenterLead Sponsor
53 Previous Clinical Trials
8,264 Total Patients Enrolled
Brian Louie, M.D.Principal InvestigatorSwedish Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have more surgeries planned.I do not speak English.I have had surgery in my chest area before.I take pain medication daily for chronic pain.I am having a minimally invasive esophagectomy at Swedish Medical Center-First Hill.I am under 18 years old.I am unable to give consent by myself.I cannot have spinal anesthesia due to certain health conditions or treatments.
Research Study Groups:
This trial has the following groups:- Group 1: local intercostal nerve block
- Group 2: cryo-ablation plus intercostal nerve block
- Group 3: serratus plane catheter plus intercostal nerve block
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for participants in this research study?
"Clinicaltrials.gov has recently been updated to show that this study is now recruiting participants; it was posted on April 26th 2022 and last amended on June 7th 2023."
Answered by AI
How many participants have joined this experiment thus far?
"Affirmative. The clinicaltrial.gov database suggests that this medical research is actively recruiting participants, with the original posting date being on April 26th 2022 and a recent edit taking place on June 7th 2023. This trial needs to recruit 30 patients from one site for successful completion."
Answered by AI
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