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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02038491
Other study ID # 20090016600
Secondary ID PT SM 05 Ricalor
Status Completed
Phase N/A
First received January 13, 2014
Last updated January 16, 2014
Start date May 2009
Est. completion date March 2013

Study information

Verified date January 2014
Source IRCCS Policlinico S. Matteo
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Procedure:
regional anesthesia
Spinal, epidural, combined spinal epidural, nerve blocks

Locations

Country Name City State
Italy IRCCS Policlinico S Matteo Pavia

Sponsors (1)

Lead Sponsor Collaborator
IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary 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 Yes
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