Catheter Redosing of Autonomic Neural Blockade After Sleeve Gastrectomy

Официальное название

Targeted Temporary In Situ Catheter Redosing of Autonomic Neural Blockade for Breakthrough Symptoms After Laparoscopic Sleeve Gastrectomy

Обзор

Postoperative visceral pain and autonomic symptoms after laparoscopic sleeve gastrectomy may reappear earlier in selected high-risk patients despite standard intraoperative autonomic neural blockade (ANB). Temporary in situ catheter placement permits postoperative ANB redosing when breakthrough visceral symptoms occur. This prospective single-arm observational study will evaluate the feasibility, safety, and clinical effectiveness of temporary ANB catheter placement and selective postoperative redosing in high-risk patients undergoing laparoscopic sleeve gastrectomy.

Подробное описание

Autonomic neural blockade (ANB) selectively modulates visceral pain and autonomic symptoms after minimally invasive upper gastrointestinal surgery. Prior randomized trials have demonstrated reductions in pain, analgesic requirements, PONV, and anesthetic consumption following ANB during laparoscopic sleeve gastrectomy (LSG). However, breakthrough visceral symptoms may occur in selected patients after blockade wanes.

A prior feasibility study by our group demonstrated that temporary in situ catheter placement for postoperative ANB redosing after LSG is technically feasible and safe, establishing catheter selection, placement strategy, and anatomical targets.

This prospective pilot study evaluates the clinical utility of selective postoperative ANB redosing in predefined high-risk patients.

All participants will undergo standard intraoperative ANB, TAP block, and temporary catheter placement in one of three anatomically validated paragastric/celiac pathway locations. Scheduled acetaminophen will be administered postoperatively.

Prior to any redosing, the treating investigator will clinically assess whether symptoms are consistent with visceral/autonomic breakthrough rather than somatic/incisional pain. Pain characteristics suggesting visceral origin include diffuse, deep, poorly localized epigastric/substernal discomfort, associated nausea/vomiting, autonomic symptoms, or pain disproportionate to abdominal wall tenderness.

Patients meeting redosing criteria will receive catheter redosing with 15 mL of 0.5% bupivacaine plus 4 mg dexamethasone. The minimum interval between re-dosing will be eight hours.

Concomitant hiatal hernia repair will be recorded for all patients, given the potential influence of distal phrenic nerve blockade on postoperative symptom patterns.

Вмешательства

• Другое Bupivacaine 0.5% and Dexamethasone via Temporary Catheter
  Autonomic neural blockade (ANB) re-dosing will be performed by administering bupivacaine 0.5% and dexamethasone through a temporary catheter placed in the paragastric area during laparoscopic sleeve gastrectomy

Первичные конечные точки

• Clinical Response to autonomic neural blockade(ANB) Redosing [Срок оценки: Up to 24 hours postoperatively]
• Resolution of Postoperative Nausea or Vomiting After ANB Re-dosing [Срок оценки: Up to 24 hours postoperatively]
• Proportion of Participants With Successful Temporary Catheter Placement and Function [Срок оценки: Intraoperative through 24 hours postoperatively]

Вторичные конечные точки (6)

• Incidence of Clinically Significant Breakthrough Visceral Symptoms Despite Standard Intraoperative ANB [Срок оценки: Up to 24 hours postoperatively]
• Number of Re-dosing Events Per Patient [Срок оценки: Up to 24 hours postoperatively]
• Safety of Temporary ANB Catheter Technique [Срок оценки: 8 postoperative days]
• Postoperative Pain Scores Compared with Historic Institutional Controls [Срок оценки: 8, 24, and 48 hours postoperatively]
• Postoperative Nausea and Vomiting Compared with Historic Institutional Controls [Срок оценки: 8, 24, and 48 hours postoperatively]
• Re-dosing Requirement by Concomitant Hiatal Hernia Repair Status [Срок оценки: Up to 24 hours postoperatively.]

Критерии участия

Критерии включения

Patients undergoing elective laparoscopic sleeve gastrectomy with one or more of the following risk factors for breakthrough visceral/autonomic symptoms:

• Female sex age <30 years
• Prior history of severe postoperative pain after abdominal surgery
• Prior history of significant postoperative nausea/vomiting
• History of opioid intolerance or significant opioid-related adverse effects
• Allergy/intolerance to multiple postoperative analgesics/antiemetics
• Concomitant hiatal hernia repair
• Surgeon's judgment of elevated visceral symptom risk based on prior institutional experience

Exclusion Criteria:•

• Contraindication to local anesthetics or dexamethasone
• Chronic opioid dependence
• Severe psychiatric or cognitive impairment limiting symptom assessment
• Pregnancy
• Conversion to open surgery
• Inability or unwillingness to comply with the postoperative reporting protocol.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Daes, J., Luque, E., Hanssen, A. (2025). Intraoperative Autonomic Blockade: Enhancing Anesthesia and ERAS Protocols in Laparoscopic Sleeve Gastrectomy. In: Gagner, M., Ramos, A.C., Palermo, M., Noel, P., Nocca, D. (eds) The Perfect Sleeve Gastrectomy. Springer, Cham. https://doi.org/10.1007/978-3-031-77690-8_104-1
• Daes, J.; García-De La Rosa, D.; Eric M., P. Temporary in Situ Catheters to Extend Autonomic Neural Blockade After Laparoscopic Sleeve Gastrectomy: A Feasibility and Safety Study. Rev Colomb Cir 2026.
• 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, Hanssen A, Luque E, Mercado J, De la Rosa DG, Pauli EM. Effect of intraoperative autonomic neural blockade on early postoperative outcomes after laparoscopic cholecystectomy: a double-blind randomized controlled trial. Surg Endosc. 2026 Apr;40(4):2894-2901. doi: 10.1007/s00464-025-12542-2. Epub 2026 Jan 13. PMID 41530355
• 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
• Daes J, Pauli E. Autonomic Neural Blockade in Minimally Invasive Surgery. JAMA Surg. 2024 Dec 1;159(12):1433-1434. doi: 10.1001/jamasurg.2024.2334. PMID 39382864

Идентификаторы

NCT: NCT07655908 · CI0012026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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