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Not Yet RecruitingNCT07238933

Neurological Events and Unforeseen Risks After Locoregional-anesthesia

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
3,396 (estimated)
Sponsor
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
OTHERObservational assessment after regional anesthesiaAdult 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.

Timeline

Start date
2025-12-01
Primary completion
2027-01-01
Completion
2027-01-01
First posted
2025-11-20
Last updated
2025-11-20

Source: ClinicalTrials.gov record NCT07238933. Inclusion in this directory is not an endorsement.