Clinical trial NCT05906134: 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
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Postoperative Pain, Acute
Postoperative Complications
Lead sponsor: Swedish Medical Center
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Post Operative Pain Change Over Time
timeFrame: Baseline (prior to OR) to every 12 hours postoperatively thru Post Operative Day 4.
measure: Post Operative Pain
timeFrame: Baseline (Prior to OR)
measure: Post Operative Pain
timeFrame: Post-Op Time 0
measure: Post Operative Pain Day 1 (AM)
timeFrame: Post Operative Day 1 (AM)
measure: Post Operative Pain Day 1 (PM)
timeFrame: Post Operative Day 1 (PM)
measure: Post Operative Pain Day 2 (AM)
timeFrame: Post Operative Day 2 (AM)
measure: Post Operative Pain Day 2 (PM)
timeFrame: Post Operative Day 2 (PM)
measure: Post Operative Pain Day 3 (AM)
timeFrame: Post Operative Day 3 (AM)
measure: Post Operative Pain Day 3 (PM)
timeFrame: Post Operative Day 3 (PM)
measure: Post Operative Pain Day 4 (AM)
timeFrame: Post Operative Day 4 (AM)
measure: Post Operative Pain Day 4 (PM)
timeFrame: Post Operative Day 4 (PM)
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
Study officials:
affiliation: Swedish Cancer Institute
name: Brian Louie, M.D.
role: PRINCIPAL_INVESTIGATOR
References: