Spinal HematomaRICALORNCT02038491
RICALOR Italian Registry for Complications During Regional Anesthesia
An observational study of Spinal Hematoma and Spinal Abscess, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Hematoma, Spinal Abscess, Neurologic Manifestations
- What is being tested?
- regional anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 63,692 participants
- Where
- 1 siteItaly
- Study dates
- May 2009to Mar 2013
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients undergoing surgery with regional anesthesia during study period will be considered for complications' incidence calculation .
Who may be able to join
- M/F
- undergoing surgery or procedures needing regional anesthesia
- signed informed consent for data treatment
Who cannot join
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Spinal Hematoma, Spinal Abscess, Neurologic Manifestations, Cardiovascular Diseases, Respiratory Failure
- Being tested
- regional anesthesia
- Keywords
- Epidural anesthesia, Spinal anesthesia, nerve blocks, complications
- Medical subject headings
- Neurologic Manifestations, Cardiovascular Diseases, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional anesthesiaProcedure or surgery
Spinal, epidural, combined spinal epidural, nerve blocks
| Study group | Role | What they receive |
|---|---|---|
| regional anesthesia | patients undergoing regional anesthesia procedures Receives: Procedure: regional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
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.
Measured: up to dismission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startMay 2009
- Primary completionMay 2009
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal HematomaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63,692 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Allegri, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038491
- Sponsor's protocol ID
- 20090016600
- Other IDs
- PT SM 05 Ricalor
- Acronym
- RICALOR
- Status last verified
- Jan 2014
- First submitted
- 13 Jan 2014
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bugada Dario; Allegri Massimo; RICALOR Group investigators; Zadra Nicola; Braschi Antonio ; Borghi Battista; Grossi Paolo.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RICALOR - Registro Italiano Complicanze Anestesia LOco Regionale - Italian Registry for Complications During Regional Anesthesia
- ClinicalTrials.gov ID
- NCT02038491
- Acronym / sponsor ID
- RICALOR / 20090016600
- Conditions
- Spinal Hematoma, Spinal Abscess, Neurologic Manifestations, Cardiovascular Diseases, Respiratory Failure
- Keywords
- Epidural anesthesia, Spinal anesthesia, nerve blocks, complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63,692 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 16 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| regional anesthesia | – | Procedure: regional anesthesiapatients undergoing regional anesthesia procedures |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing surgery with regional anesthesia during study period will be considered for complications' incidence calculation .
Key inclusion criteria (3 listed)
- M/F
- undergoing surgery or procedures needing regional anesthesia
- signed informed consent for data treatment
Key exclusion criteria (1 listed)
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| regional anesthesiaSpinal, epidural, combined spinal epidural, nerve blocks | Procedure or surgery | regional anesthesia |
Primary outcome
number of subjects presenting complications associated with regional anesthesia techniques
Time frame: 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
1 secondary outcome
statistically significant difference in cases (complication) and controls regarding factors potentially affecting complications' occurrence
Time frame: up to dismission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2014.
- BackgroundBugada Dario; Allegri Massimo; RICALOR Group investigators; Zadra Nicola; Braschi Antonio ; Borghi Battista; Grossi Paolo.
- Related InfoLink provided by the sponsor.
Related trials for Spinal Hematoma
RecruitingObservational study
Establishment of Clinical Prediction Model for Postoperative Symptomatic Spinal Epidural Hematoma
Spinal Epidural Hematoma
Not yet recruitingObservational study
Outcomes of Traumatic Intracranial Hemorrhage in the Elderly
Traumatic Brain Injury, Subdural Hematoma
RecruitingObservational study
Neurosurgical Outcome Network
Aneurysms, Arteriovenous Malformations
RecruitingObservational study
Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases
Epidural Hematoma, Decompressive Craniectomy
Active, not recruiting
Prospective Randomized Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic Acute Epidural Hematoma
Epidural Hematoma, Brain Herniation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Hematoma and Spinal Abscess, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of subjects presenting complications associated with regional anesthesia techniques (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02038491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2014.