RICALOR Italian Registry for Complications During Regional Anesthesia
NCT ID: NCT02038491
Last Updated: 2014-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
63692 participants
OBSERVATIONAL
2009-05-31
2013-03-31
Brief Summary
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RICALOR Group Investigators developed a national registry to register the incidence of regional anesthesia-associated complications and to identify possible risk factors.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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regional anesthesia
patients undergoing regional anesthesia procedures
regional anesthesia
Spinal, epidural, combined spinal epidural, nerve blocks
Interventions
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regional anesthesia
Spinal, epidural, combined spinal epidural, nerve blocks
Eligibility Criteria
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Inclusion Criteria
* undergoing surgery or procedures needing regional anesthesia
* signed informed consent for data treatment
Exclusion Criteria
ALL
No
Sponsors
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Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
Responsible Party
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Massimo Allegri
MD
Locations
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IRCCS Policlinico S Matteo
Pavia, , Italy
Countries
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References
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Bugada Dario; Allegri Massimo; RICALOR Group investigators; Zadra Nicola; Braschi Antonio ; Borghi Battista; Grossi Paolo.
Related Links
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Related Info
Other Identifiers
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PT SM 05 Ricalor
Identifier Type: OTHER
Identifier Source: secondary_id
20090016600
Identifier Type: -
Identifier Source: org_study_id
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