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RecruitingNCT07238933NEURALUpdated Sep 11, 2026

Neurological Events and Unforeseen Risks After Locoregional-anesthesia

An observational study in Regional Anesthesia and Regional Anesthesia Block, sponsored by Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva. Recruiting at 4 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,396
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Regional Anesthesia
  • Regional Anesthesia Block

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Keywords

  • Nerve Injury
  • Pneumothorax
  • Local Anesthetic Systemic
  • Toxicity
  • Upper limb block
  • Lower limb block
  • Fascial plane block
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients (≥18 years) undergoing single-shot locoregional anesthesia of the upper limb, lower limb, or fascial blocks.

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,396 participants (estimated)
Patient registry
No

Groups and cohorts

  • Single group of enrolled patients

    Adult patients (≥18 years) undergoing single-shot upper limb, lower limb, or fascial plane regional anesthesia. All participants meeting inclusion criteria and providing informed consent will be enrolled consecutively.

    Other: Observational assessment after regional anesthesia

Interventions

  • OtherObservational 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 vastus medialis, genicular, IPACK, common peroneal, ankle, and pudendal blocks. Fascial plane blocks - rectus sheath, ilioinguinal/iliohypogastric, TAP (standard/subcostal/midaxillary), ESP, serratus anterior (deep/superficial), parasternal intercostal (superficial/deep), interpectoral, transversalis fascia, rhomboid intercostal, retrolaminar, quadratus lumborum (anterior/lateral/posterior), paravertebral, intertransverse process, and pectoserratus blocks.

05

What researchers measure

Primary outcomes

  1. Incidence of Composite Complications Following Single-Shot Locoregional Anesthesia

    Incidence of any major complication - including nerve injury, hematoma requiring medical intervention, pneumothorax, or local anesthetic systemic toxicity (LAST) - following single-shot locoregional anesthesia. The rate is calculated as the number of procedures with at least one complication divided by the total number of procedures performed.

    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 outcomes

  1. Incidence of Complications in Upper Limb Nerve Blocks

    Incidence of each complication type (nerve injury, hematoma, pneumothorax, LAST) following upper limb single-shot nerve blocks. Calculated as the number of events divided by the total number of upper limb procedures

    Time frame: From the procedure to 30 days post-procedure.

  2. Incidence of Complications in Fascial Plane Blocks

    Incidence of each complication type (nerve injury, hematoma, pneumothorax, LAST) following fascial plane single-shot blocks.

    Time frame: From the procedure to 30 days post-procedure.

  3. (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Age

    Measured in years

    Time frame: Baseline

  4. (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Gender

    Using a dichotomic male/female framework

    Time frame: Baseline

  5. (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Body Mass Index

    Calculated dividing a person's weight in kilograms by the square of their height in meters (BMI = weight ÷ height²) (kg/cm²)

    Time frame: Baseline

  6. (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Presence of comorbidities

    Hypertension, diabetes, and central or peripheral neuropathies each expressed dichotomically as "Yes" (present) or "No" (absent).

    Time frame: Baseline

  7. (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Use of anticoagulant or antiplatelet therapy

    Use of anticogulants and/or antiplatetets drugs expressed as a Yes or No

    Time frame: Baseline

  8. (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Use of sedative during the block procedure

    Use of any sedative agents during the block procedure reported as a Yes or No

    Time frame: Periprocedural

  9. (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Pain at injection

    Reported pain during the injection of local anesthetics expressed as a Yes or No

    Time frame: Baseline

  10. (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Ultrasound guidance

    Use of ultrasound guidance to perform the block, measured with a "Yes" or "No" variable

    Time frame: Periprocedural

  11. (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Local anesthetic used to perform the block

    Name, volume(ml) and dose(mg) of the local anesthetic used to perform the block

    Time frame: Periprocedural

  12. (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Adjuvants used to perform the block

    Name, volume(ml) and dose(mcg) of the adjuvants used to perform the block

    Time frame: Periprocedural

06

Study locations

1 of 4 sites recruiting
  • ASST Papa Giovanni XXIII
    Bergamo, Bergamo 24127, Italy
    Not yet recruiting
  • Spedali Civili di Brescia
    Brescia, Brescia 25123, Italy
    Not yet recruiting
  • Irccs Humanitas Research Hospital
    Rozzano, Milan 20089, Italy
    Not yet recruiting
  • Azienda Ospedale-Università Padova
    Padova, Padova 35128, Italy
    Recruiting
07

References and documents

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. PubMed 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. PubMed 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. PubMed 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, Karmakar MK, Kessler P, Kwofie K, Lobo C, Ludwin D, MacFarlane A, McDonnell J, McLeod G, Merjavy P, Moran E, O'Donnell BD, Parras T, Pawa A, Perlas A, Rojas Gomez MF, Sala-Blanch X, Saporito A, Sinha SK, Soffin EM, Thottungal A, Tsui BCH, Tulgar S, Turbitt L, Uppal V, van Geffen GJ, Volk T, Elkassabany NM. Standardizing nomenclature in regional anesthesia: an ASRA-ESRA Delphi consensus study of abdominal wall, paraspinal, and chest wall blocks. Reg Anesth Pain Med. 2021 Jul;46(7):571-580. doi: 10.1136/rapm-2020-102451. PubMed 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, Gautier PE, Grant SA, Grape S, Guheen C, Harbell MW, Hebbard P, Hernandez N, Hogg RMG, Holtz M, Ihnatsenka B, Ilfeld BM, Ip VHY, Johnson RL, Kalagara H, Kessler P, Kwofie MK, Le-Wendling L, Lirk P, Lobo C, Ludwin D, Macfarlane AJR, Makris A, McCartney C, McDonnell J, McLeod GA, Memtsoudis SG, Merjavy P, Moran EML, Nader A, Neal JM, Niazi AU, Njathi-Ori C, O'Donnell BD, Oldman M, Orebaugh SL, Parras T, Pawa A, Peng P, Porter S, Pulos BP, Sala-Blanch X, Saporito A, Sauter AR, Schwenk ES, Sebastian MP, Sidhu N, Sinha SK, Soffin EM, Stimpson J, Tang R, Tsui BCH, Turbitt L, Uppal V, van Geffen GJ, Vermeylen K, Vlassakov K, Volk T, Xu JL, Elkassabany NM. Standardizing nomenclature in regional anesthesia: an ASRA-ESRA Delphi consensus study of upper and lower limb nerve blocks. Reg Anesth Pain Med. 2024 Nov 4;49(11):782-792. doi: 10.1136/rapm-2023-104884. PubMed 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. PubMed 35777259 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT07238933
Lead sponsor
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
Responsible party
Sponsor
First posted
Nov 20, 2025
Start date
Feb 18, 2026
Primary completion
Jan 1, 2027 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Sep 11, 2026

Study contacts

Cristina Cacciagrano Clinical Reasearch Office SIAARTI
Contact
ricerca@siaarti.it
+39 06 4452816
Alessandro De Cassai Prof., MD
principal investigator · UOC Istituto di Anestesia e Rianimazione, Azienda Ospedale Università di Padova

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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