Health TrialsbyHealthPanel

Neurological Events and Unforeseen Risks After Locoregional-anesthesia

ConditionsRegional AnesthesiaRegional Anesthesia Block
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSocieta Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Scheduled to undergo a single-shot nerve or fascial plane block.

Ability to provide written informed consent.

Disqualifiers

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 population

Adult patients (≥18 years) undergoing single-shot locoregional anesthesia of the upper limb, lower limb, or fascial blocks.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational assessment after regional anesthesia

    Other intervention

    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.

Treatment groups

3,396 Participants
are divided into 1 treatment group
Group A: Single group of enrolled patients1 intervention

Trial outcomes

Primary outcomes

1

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).

Secondary outcomes

1

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.
2

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.
3

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

Measured in years

Time frame
Baseline
4

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

Using a dichotomic male/female framework

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva

Lead sponsor

Source ClinicalTrials.gov
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