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Идёт набор NCT07104825

Autonomic Neural Blockade in Bariatric Surgery

Без фазы С лечением Bariatric Surgery Candidate Pain, Postoperative Nausea and Vomiting, Postoperative Opioid Use

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Intraoperative autonomic neural blockade (ANB), Laparoscopic Standard of Care Abdominal Wall Block.
Кому может быть актуально
Состояния в реестре: Bariatric Surgery Candidate, Pain, Postoperative, Nausea and Vomiting, Postoperative, Opioid Use. Базовые параметры: 18 лет — 90 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Autonomic Neural Blockade During Sleeve Gastrectomy and Gastric Bypass: A Randomized Controlled Trial Evaluating Pain and Nausea After Bariatric Surgery

Обзор

The purpose of this research is to evaluate if autonomic nerve block (ANB- blocking pain and nausea signals) decreases pain and anti-nausea medication requirements as well as the experience of pain/nausea during the first 72 hours after sleeve gastrectomy or gastric bypass surgery. Participants will be randomly assigned either to the standard of care or the ANB group before surgery. As part of standard of care, in both groups, laparoscopic bariatric surgery will be initiated with local anesthetic injected into the abdominal wall. In the ANB group, participants will be given an additional injection of local anesthetic medication to block nerves on and around the stomach.

Подробное описание

Gastric bypass and sleeve gastrectomy are the most common and successful weight loss surgeries. The advancement of laparoscopic, minimally invasive techniques allows these procedures to be performed with low morbidity and a relatively easy recovery, when broadly considering abdominal surgery. The major complaints postoperatively are abdominal pain and nausea, which can require medications to control and may prolong hospital stay. There is evidence autonomic neural blockade (ANB) improves pain and nausea in the immediate postoperative period. ANB has been shown to be therapeutic in the surgical environment providing extended analgesia for pain following surgery.

This study is a single-blinded randomized controlled trial comparing the total morphine milligram equivalents (MMEs) of pain medication used 72 hours post-operative period in patients who received the ANB vs standard of care. In the ANB group, additional local anesthetic block of the neurovascular tissue along the lesser curve of the stomach and celiac trunk will be performed using 0.5% bupivacaine 10ml, 50mg and Liposomal bupivacaine 10ml, 133mg dose. Study participants will not be told if they received the block, but the surgeon will be aware of which study group participants are assigned.

Вмешательства

  • Процедура Intraoperative autonomic neural blockade (ANB)
    Local anesthetic block of the neurovascular tissue along the lesser curve of the stomach and celiac trunk during sleeve gastrectomy or gastric bypass surgery.
  • Процедура Laparoscopic Standard of Care Abdominal Wall Block
    Administration of local anesthetic to abdominal incisions (standard of care)

Первичные конечные точки

  • Pain medication consumed post-operatively [Срок оценки: Post-op 72 hours]
Вторичные конечные точки (2)
  • Numerical Pain Rating Scale [Срок оценки: Day of surgery, post-op days 1, 2 and 3.]
  • Nausea, retching and vomiting symptoms [Срок оценки: Post-op days 1, 2 and 3.]

Критерии участия

Критерии включения

  • Individuals able and willing to consent and participate in all study activities
  • Adults, ages 18-90
  • All patients with severe obesity undergoing laparoscopic/robotic gastric bypass or sleeve gastrectomy

Критерии исключения

  • Patients taking opiates chronically
  • Patients allergic to study medications
  • Patients with any prior adverse reaction to ingredients included in the block
  • Adults unable to consent
  • Pregnant women
  • Prisoners

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
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Endeavor Health — Evanston

Публикации

  • Daes J, Pantoja R, Luque E, Hanssen A, Rocha J, Pauli EM. Intraoperative autonomic neural blockade: comparison between different local anesthetics combinations: a randomized clinical trial. Surg Endosc. 2025 Apr;39(4):2523-2533. doi: 10.1007/s00464-025-11637-0. Epub 2025 Mar 3. PMID 40032662
  • Daes J, Pantoja R, Luquetta J, Luque E, Hanssen A, Rocha J, Morrell DJ. Impact on Anesthetic Agent Consumption After Autonomic Neural Blockade as Part of a Combined Anesthesia Protocol: A Randomized Clinical Trial. Anesth Analg. 2024 Sep 1;139(3):581-589. doi: 10.1213/ANE.0000000000006769. Epub 2023 Dec 13. PMID 38091501
  • Daes J, Morrell DJ, Hanssen A, Caballero M, Luque E, Pantoja R, Luquetta J, Pauli EM. Paragastric Autonomic Neural Blockade to Prevent Early Visceral Pain and Associated Symptoms After Laparoscopic Sleeve Gastrectomy: a Randomized Clinical Trial. Obes Surg. 2022 Nov;32(11):3551-3560. doi: 10.1007/s11695-022-06257-9. Epub 2022 Sep 2. PMID 36050617

Идентификаторы

NCT: NCT07104825 · STUDY00000229

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗