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NCT Number: NCT07238933

Neurological Events and Unforeseen Risks After Locoregional-anesthesia

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.

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Key information

Conditions

Regional Anesthesia Pleural Diseases Pneumothorax Regional Anesthesia Block Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational assessment after regional anesthesia

Other

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.

Primary outcomes

  1. 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).

    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.

Secondary outcomes

  1. Incidence of Complications in Upper Limb Nerve Blocks

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

    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

  2. Incidence of Complications in Fascial Plane Blocks

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

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

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

    Time frame: Baseline

    Measured in years

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

    Time frame: Baseline

    Using a dichotomic male/female framework

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Baseline

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

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

    Time frame: Periprocedural

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

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

    Time frame: Baseline

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

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

    Time frame: Periprocedural

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

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

    Time frame: Periprocedural

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

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

    Time frame: Periprocedural

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

Study contacts

Contact information is provided by the study sponsor or research team.

Cristina Cacciagrano Clinical Reasearch Office SIAARTI

CONTACT

[email protected]

+39 06 4452816

Sponsors and collaborators

Lead sponsor

Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva

Other

Registry information

Acronym: NEURAL

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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