Minimally Invasive Esophagectomy Pain Control Trial

Postoperative Complications Clinical 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05906134
• Other study ID #: Rib Block 21181
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 26, 2022
• Est. completion date: February 2026

Study information

• Verified date: June 2023
• Source: Swedish Medical Center
• Contact: Brian Louie, M.D.
• Phone: (206) 215-6800
• Email: brian.louie[@]swedish.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Pain
• Pain, Postoperative
• Postoperative Complications

Intervention

Procedure:
• 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 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Swedish Cancer Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Swedish Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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)
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)