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NCT05906134PHASE1, PHASE2Recruiting

Minimally Invasive Esophagectomy Pain Control Trial

Swedish Medical Center

Start Date

4/26/2022

Completion Date

2/1/2027

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

Age Range: 18 years to No maximum

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)

Interventions

PROCEDURE

Local intercostal nerve block

PROCEDURE

Cryo-analgesia and intercostal nerve block

PROCEDURE

Serratus plane catheter blocks and intercostal nerve blocks

PROCEDURE

Thoracic epidural catheter

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Conditions

Postoperative Pain, AcutePostoperative Complications

Locations

Swedish Cancer Institute

Seattle, Washington 98104

United States