Minimally Invasive Esophagectomy Pain Control Trial

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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.
• Процедура 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
• Процедура 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 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.

Первичные конечные точки

• Post Operative Pain Change Over Time [Срок оценки: Baseline (prior to OR) to every 12 hours postoperatively thru Post Operative Day 4.]
• Post Operative Pain [Срок оценки: Baseline (Prior to OR)]
• Post Operative Pain [Срок оценки: Post-Op Time 0]
• Post Operative Pain Day 1 (AM) [Срок оценки: Post Operative Day 1 (AM)]
• Post Operative Pain Day 1 (PM) [Срок оценки: Post Operative Day 1 (PM)]
• Post Operative Pain Day 2 (AM) [Срок оценки: Post Operative Day 2 (AM)]
• Post Operative Pain Day 2 (PM) [Срок оценки: Post Operative Day 2 (PM)]
• Post Operative Pain Day 3 (AM) [Срок оценки: Post Operative Day 3 (AM)]
• Post Operative Pain Day 3 (PM) [Срок оценки: Post Operative Day 3 (PM)]
• Post Operative Pain Day 4 (AM) [Срок оценки: Post Operative Day 4 (AM)]

Критерии участия

Критерии включения

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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Swedish Cancer Institute — Seattle

Идентификаторы

NCT: NCT05906134 · Rib Block 21181

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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