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.
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.
Study Type
OBSERVATIONAL
Enrollment
3,396
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.
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).
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.
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.
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Age
Measured in years
Time frame: Baseline
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Gender
Using a dichotomic male/female framework
Time frame: Baseline
(Predictor of Complications in Upper Limb, Lower Limb or Fascial Plane Blocks) Body Mass Index
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Calculated dividing a person's weight in kilograms by the square of their height in meters (BMI = weight ÷ height²) (kg/cm²)
Time frame: Baseline
(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
(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
(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
(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
(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
(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
(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