Menu
Not yet recruiting NCT07238933

Neurological Events and Unforeseen Risks After Locoregional-anesthesia

— Observational Regional Anesthesia Regional Anesthesia Block

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational assessment after regional anesthesia.
Who it may be relevant to
Registry conditions: Regional Anesthesia, Regional Anesthesia Block. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

  • Other 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

Primary outcome measures

  • Incidence of Composite Complications Following Single-Shot Locoregional Anesthesia [Time frame: 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).]
Secondary outcome measures (12)
  • Incidence of Complications in Upper Limb Nerve Blocks [Time frame: From the procedure to 30 days post-procedure.]
  • Incidence of Complications in Fascial Plane Blocks [Time frame: From the procedure to 30 days post-procedure.]
  • (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Age [Time frame: Baseline]
  • (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Gender [Time frame: Baseline]
  • (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Body Mass Index [Time frame: Baseline]
  • (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Presence of comorbidities [Time frame: Baseline]
  • (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Use of anticoagulant or antiplatelet therapy [Time frame: Baseline]
  • (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Use of sedative during the block procedure [Time frame: Periprocedural]
  • (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Pain at injection [Time frame: Baseline]
  • (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Ultrasound guidance [Time frame: Periprocedural]
  • (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Local anesthetic used to perform the block [Time frame: Periprocedural]
  • (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Adjuvants used to perform the block [Time frame: Periprocedural]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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

Identifiers

NCT: NCT07238933 · NEURAL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗