Regional Anesthesia, Regional Anesthesia Block
Conditions
Keywords
Nerve Injury, Pneumothorax, Local Anesthetic Systemic, Toxicity, Upper limb block, Lower limb block, Fascial plane block
Brief 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.
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.
Sponsors
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Composite Complications Following Single-Shot Locoregional Anesthesia | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Complications in Upper Limb Nerve Blocks | 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 |
| Incidence of Complications in Fascial Plane Blocks | From the procedure to 30 days post-procedure. | Incidence of each complication type (nerve injury, hematoma, pneumothorax, LAST) following fascial plane single-shot blocks. |
| (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Age | Baseline | Measured in years |
| (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Gender | Baseline | Using a dichotomic male/female framework |
| (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Body Mass Index | Baseline | Calculated dividing a person's weight in kilograms by the square of their height in meters (BMI = weight ÷ height²) (kg/cm²) |
| (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Presence of comorbidities | Baseline | Hypertension, diabetes, and central or peripheral neuropathies each expressed dichotomically as "Yes" (present) or "No" (absent). |
| (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Use of anticoagulant or antiplatelet therapy | Baseline | Use of anticogulants and/or antiplatetets drugs expressed as a Yes or No |
| (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Use of sedative during the block procedure | Periprocedural | Use of any sedative agents during the block procedure reported as a Yes or No |
| (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Pain at injection | Baseline | Reported pain during the injection of local anesthetics expressed as a Yes or No |
| (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Ultrasound guidance | Periprocedural | Use of ultrasound guidance to perform the block, measured with a "Yes" or "No" variable |
| (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Local anesthetic used to perform the block | Periprocedural | Name, volume(ml) and dose(mg) of the local anesthetic used to perform the block |
| (Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Adjuvants used to perform the block | Periprocedural | Name, volume(ml) and dose(mcg) of the adjuvants used to perform the block |
Countries
Italy
Contacts
CONTACTCristina Cacciagrano Clinical Reasearch Office SIAARTI
PRINCIPAL_INVESTIGATORAlessandro De Cassai Prof., MD
UOC Istituto di Anestesia e Rianimazione, Azienda Ospedale Università di Padova
Outcome results
None listed