Neurological Events and Unforeseen Risks After Locoregional-anesthesia

Обзор

This is a multicenter, prospective, observational study aimed at determining the incidence of neurological and non-neurological complications following locoregional anesthesia procedures. The study will collect data on events such as nerve injury, hematoma, pneumothorax, and local anesthetic systemic toxicity.

Подробное описание

Locoregional anesthesia is generally considered safe, but rare neurological and systemic complications have been reported. Current data on the true incidence of these complications are limited and often derived from small sample sizes or registries. The NEURAL study aims to fill this knowledge gap by prospectively collecting data on complications following single-shot nerve blocks in the upper limb, lower limb, and fascial plane. In addition to incidence, the study will investigate potential risk factors for these complications.

Вмешательства

• Другое Observational assessment after regional anesthesia
  Adult patients undergoing single-shot regional anesthesia, including: Upper limb blocks - interscalene, superior trunk, supraclavicular, infraclavicular (coracoid, retroclavicular, costoclavicular), suprascapular (anterior, posterior), axillary, and superficial/intermediate/deep cervical plexus blocks. Lower limb blocks - lumbar, sacral, fascia iliaca (supra/infrainguinal), adductor canal, PENG, femoral, femoral triangle, sciatic (anterior, transgluteal, infragluteal, popliteal), nerve to vast

Первичные конечные точки

• Incidence of Composite Complications Following Single-Shot Locoregional Anesthesia [Срок оценки: From the time of the locoregional anesthesia procedure up to 30 days post-procedure (periprocedural and early postoperative period, with follow-up at 24 hours, 48 hours, 15 days, and 30 days).]

Вторичные конечные точки (12)

• Incidence of Complications in Upper Limb Nerve Blocks [Срок оценки: From the procedure to 30 days post-procedure.]
• Incidence of Complications in Fascial Plane Blocks [Срок оценки: From the procedure to 30 days post-procedure.]
• (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Age [Срок оценки: Baseline]
• (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Gender [Срок оценки: Baseline]
• (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Body Mass Index [Срок оценки: Baseline]
• (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Presence of comorbidities [Срок оценки: Baseline]
• (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Use of anticoagulant or antiplatelet therapy [Срок оценки: Baseline]
• (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Use of sedative during the block procedure [Срок оценки: Periprocedural]
• (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Pain at injection [Срок оценки: Baseline]
• (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Ultrasound guidance [Срок оценки: Periprocedural]
• (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Local anesthetic used to perform the block [Срок оценки: Periprocedural]
• (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Adjuvants used to perform the block [Срок оценки: Periprocedural]

Критерии участия

Критерии включения

• Age ≥ 18 years.
• Scheduled to undergo a single-shot nerve or fascial plane block.
• Ability to provide written informed consent.

Критерии исключения

• Performance of more than one single-shot nerve or fascial plane block within the same anatomical region or sensory distribution during the same procedure.
• Use of continuous nerve or fascial plane catheter-based anesthesia.
• Presence of a language barrier that, in the investigator's judgment, would prevent adequate follow-up.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• McLeod GA, Sadler A, Hales TG. Traumatic needle damage to nerves during regional anesthesia: presentation of a novel mechanotransduction hypothesis. Reg Anesth Pain Med. 2022 Jul 25:rapm-2022-103583. doi: 10.1136/rapm-2022-103583. Online ahead of print. PMID 35878962
• Gitman M, Fettiplace MR, Weinberg GL, Neal JM, Barrington MJ. Local Anesthetic Systemic Toxicity: A Narrative Literature Review and Clinical Update on Prevention, Diagnosis, and Management. Plast Reconstr Surg. 2019 Sep;144(3):783-795. doi: 10.1097/PRS.0000000000005989. PMID 31461049
• Neal JM, Barrington MJ, Brull R, Hadzic A, Hebl JR, Horlocker TT, Huntoon MA, Kopp SL, Rathmell JP, Watson JC. The Second ASRA Practice Advisory on Neurologic Complications Associated With Regional Anesthesia and Pain Medicine: Executive Summary 2015. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):401-30. doi: 10.1097/AAP.0000000000000286. PMID 26288034
• El-Boghdadly K, Wolmarans M, Stengel AD, Albrecht E, Chin KJ, Elsharkawy H, Kopp S, Mariano ER, Xu JL, Adhikary S, Altiparmak B, Barrington MJ, Bloc S, Blanco R, Boretsky K, Borglum J, Breebaart M, Burckett-St Laurent D, Capdevila X, Carvalho B, Chuan A, Coppens S, Costache I, Dam M, Egeler C, Fajardo M, Gadsden J, Gautier PE, Grant SA, Hadzic A, Hebbard P, Hernandez N, Hogg R, Holtz M, Johnson RL PMID 34145070
• El-Boghdadly K, Albrecht E, Wolmarans M, Mariano ER, Kopp S, Perlas A, Thottungal A, Gadsden J, Tulgar S, Adhikary S, Aguirre J, Agur AMR, Altiparmak B, Barrington MJ, Bedforth N, Blanco R, Bloc S, Boretsky K, Bowness J, Breebaart M, Burckett-St Laurent D, Carvalho B, Chelly JE, Chin KJ, Chuan A, Coppens S, Costache I, Dam M, Desmet M, Dhir S, Egeler C, Elsharkawy H, Bendtsen TF, Fox B, Franco CD, PMID 38050174
• Long B, Chavez S, Gottlieb M, Montrief T, Brady WJ. Local anesthetic systemic toxicity: A narrative review for emergency clinicians. Am J Emerg Med. 2022 Sep;59:42-48. doi: 10.1016/j.ajem.2022.06.017. Epub 2022 Jun 13. PMID 35777259

Идентификаторы

NCT: NCT07238933 · NEURAL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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