RICALOR Italian Registry for Complications During Regional Anesthesia (RICALOR)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Neurologic Manifestations; Respiratory Failure; Spinal Hematoma; Spinal Abscess
• Intervention / Treatment: Procedure: regional anesthesia

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 63692

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • IRCCS Policlinico S Matteo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients undergoing surgery with regional anesthesia during study period will be considered for complications' incidence calculation .

Description

Inclusion Criteria:

• M/F
• undergoing surgery or procedures needing regional anesthesia
• signed informed consent for data treatment

Exclusion Criteria:

• no informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
regional anesthesia; patients undergoing regional anesthesia procedures	Procedure: regional anesthesia; Spinal, epidural, combined spinal epidural, nerve blocks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of subjects presenting complications associated with regional anesthesia techniques	Number of subjects presenting complications associated with regional anesthesia is recorded, and when a neurologic deficit could occur, we monitor the patient for at least 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
statistically significant difference in cases (complication) and controls regarding factors potentially affecting complications' occurrence	Case control analysis to identify risk factors connected with major complications. Analyzed variables will be: demographic variables, emergency/election surgery, equipment (needles, type of guidance), tourniquet, patients position, drugs dosing regimen, anti-thrombotic therapy, type of surgery, operator experience, type of block.	up to dismission

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Matteo

Publications and helpful links

General Publications

• Bugada Dario; Allegri Massimo; RICALOR Group investigators; Zadra Nicola; Braschi Antonio ; Borghi Battista; Grossi Paolo.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: January 13, 2014
• First Submitted That Met QC Criteria: January 14, 2014
• First Posted (Estimate): January 16, 2014

Study Record Updates

• Last Update Posted (Estimate): January 17, 2014
• Last Update Submitted That Met QC Criteria: January 16, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: complications; Spinal anesthesia; nerve blocks; Epidural anesthesia
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Hemorrhage; Cardiovascular Diseases; Respiratory Insufficiency; Hematoma; Neurologic Manifestations; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 20090016600; PT SM 05 Ricalor (Other Identifier: Policlinico S Matteo Pavia Italy)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No