Neurological Events and Unforeseen Risks After Locoregional-anesthesia (NEURAL)

Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva

Status: Not yet enrolling

Conditions: Regional Anesthesia Block; Regional Anesthesia

Treatments: Other: Observational assessment after regional anesthesia

Study type: Observational

Funder types: Other

Identifiers

NCT07238933

NEURAL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,396 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,396 participants in 1 patient group

Single group of enrolled patients

Description:

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.

Treatment:

Other: Observational assessment after regional anesthesia