Cardiovascular Diseases Clinical Trial
Official title:
RICALOR - Registro Italiano Complicanze Anestesia LOco Regionale - Italian Registry for Complications During Regional Anesthesia
Regional anesthesia is the cornerstone of modern postoperative analgesia, but concerns
remain about possible adverse effects and complication.
RICALOR Group Investigators developed a national registry to register the incidence of
regional anesthesia-associated complications and to identify possible risk factors.
The project has been advertised through direct contact with relevant organizations in
anaesthesia and pain management. Any other center willing to participate is provided with
all the documents to receive its local Institutional Review Board (IRB) approval, and a
'local responsible' (LR) is nominated to co-ordinate the project and to be responsible of
data collection locally.
Centers receiving IRB approval collect data about different types of procedure (adult major
and minor surgery, pediatric surgery, obstetric anesthesia, pain management). Data are
collected on a specifically designed form, and every center quarterly sent the promoter
centre a report including general data and a specific report for every occurred
complication.
Eligibility criteria
Investigators collect the total number of intervention and the number of regional
anesthesia(RA) techniques performed . Patients recorded as "case" and "controls" had to sign
a specifical informed consent. For pediatric patients and patients not able to sign for any
reason, a specific form is included in the document, to be signed by parents or any
legally-established tutor, as required for every clinical procedure or scientific trial in
our country.
General data
Total number of interventions, the number of central neuraxial block (CNBs), peripheral
nerve blocks (PNBs) and continuous PNBs (CPNBs) performed. CNBs are classified as epidurals,
combined spinal-epidurals (CSEs), subarachnoid. PNBs and cPNBs are divided into
ultrasound-guided, nerve stimulation-guided and blind techniques.
Specific data - report for complications
For each complication a specific report is sent for data analysis, including data concerning
cases (patient with complication) and controls (the two following patients undergoing the
same type of loco-regional technique).
Reports are slightly different for CNBs and (c)PNBs. For every patient, the investigators
register demographic data (age, ASA-American Society of Anesthesiologists- status, height
and weight), data regarding surgical technique (type of surgery,
open/video-laparoscopic/robotic approach, election/emergency surgery) and data regarding
anti-thromboembolic therapy (drugs, timing of suspension before/after blockade).
A second part of the report is strictly dedicated to the technique and to the type of
complication occurred (and, hence, different in central and peripheral blocks).
Statistical analysis
Study population is estimated basing on previous studies of major complications after CNBs,
which indicate an incidence of major adverse effects of 4.2 on 100.000 patients. Estimating
an incidence of 1:25.000, a number of 25.000 procedures was calculated to be needed for the
study, with a confidence interval of 95%. The primary endpoint was to assess cumulative
incidence of adverse effects, while a following case-control analysis will be performed to
identify possible risk factors.
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Observational Model: Cohort, Time Perspective: Prospective
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