- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02038491
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
-
-
-
Pavia, Włochy, 27100
- IRCCS Policlinico S Matteo
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- M/F
- undergoing surgery or procedures needing regional anesthesia
- signed informed consent for data treatment
Exclusion Criteria:
- no informed consent
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: Kohorta
- Perspektywy czasowe: Spodziewany
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
---|---|
regional anesthesia
patients undergoing regional anesthesia procedures
|
Spinal, epidural, combined spinal epidural, nerve blocks
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
number of subjects presenting complications associated with regional anesthesia techniques
Ramy czasowe: 6 months
|
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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
statistically significant difference in cases (complication) and controls regarding factors potentially affecting complications' occurrence
Ramy czasowe: up to dismission
|
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
|
Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- Bugada Dario; Allegri Massimo; RICALOR Group investigators; Zadra Nicola; Braschi Antonio ; Borghi Battista; Grossi Paolo.
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 20090016600
- PT SM 05 Ricalor (Inny identyfikator: Policlinico S Matteo Pavia Italy)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .