RecruitingPhase 1Phase 2NCT05906134

Minimally Invasive Esophagectomy Pain Control Trial

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


Sponsor

Swedish Medical Center

Enrollment

30 participants

Start Date

Apr 26, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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:
  • -hole with R video-assisted thoracoscopic surgery (VATS)
  • Ivor Lewis R VATS

Exclusion Criteria7

  • 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)

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Interventions

PROCEDURELocal 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.

PROCEDURECryo-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.

PROCEDURESerratus 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.

PROCEDUREThoracic 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 likely consist of a thoracic epidural catheter. Any additional pain control will be added as an adjunct to the study arm and will be noted in the data set.


Locations(1)

Swedish Cancer Institute

Seattle, Washington, United States

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NCT05906134


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