Anesthesia, SpinalNCT04161586
Prilocaine for Spinal Anesthesia in Ambulatory Setting
An observational study of Anesthesia, Spinal and Prilocaine, run by Ospedale di Circolo - Fondazione Macchi at 1 site in Italy.
Trial summary
The purpose of this study is to retrospectively analyze data from more than 3000 procedures, to better define the safety profile of spinal prilocaine and the incidence of complications and side effects. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anesthesia, Spinal, Prilocaine, Ambulatory Surgical Procedures
- What is being tested?
- Prilocaine Hydrochloride
- How many people
- 3,291 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2011to 9 Nov 2019
- 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 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Single Center Ambulatory Surgical Patients
Who may be able to join
- Ambulatory surgical procedures performed under spinal anesthesia with Prilocaine
Who cannot join
- General Anesthesia
- Procedures lasting longer than 2 hours
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Day Surgery Ospedale di Circolo Varese
Varese, VA, 21100
About this study
Official title: Prilocaine for Spinal Anesthesia in Ambulatory Setting: an Observational Retrospective Study
The purpose of this study is to retrospectively analyze data from more than 3000 procedures, to better define the safety profile of spinal prilocaine and the incidence of complications and side effects.
Read the detailed description
We designed a retrospective cohort study to analyze the safety profile and the incidence of side effects associated with prilocaine for spinal anesthesia in ambulatory settings.
Data will be obtained from an internal database where are prospectively recorded clinical data from spinal anesthesia consecutively performed with prilocaine at our institution for ambulatory surgery from 2011 to 2019. Variables recorded in the database and analyzed will include demographic data, type of surgery, presence of surgical, anesthesiological or general complications, need for unplanned admission and percentage of completed database records.
- Being tested
- Prilocaine Hydrochloride
- Keywords
- Spinal Anesthesia, Prilocaine, Ambulatory Surgery, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prilocaine HydrochlorideDrug
Also called Spinal Anesthesia
Spinal Prilocaine for Ambulatory Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
anesthesia-related complication
urinary retention, lipotimia, postoperative nausea, arrhythmia, hypotension, transient neurological symptoms, headache
Measured: 2011-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start1 Jan 2011
- Primary completion30 Jun 2019
- Study completion9 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, SpinalStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 3,291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale di Circolo - Fondazione Macchi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Luigi Ambrosoli, Ospedale di Circolo - Fondazione Macchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161586
- Sponsor's protocol ID
- VAR-005
- Status last verified
- Nov 2019
- First submitted
- 9 Nov 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prilocaine for Spinal Anesthesia in Ambulatory Setting: an Observational Retrospective Study
- ClinicalTrials.gov ID
- NCT04161586
- Acronym / sponsor ID
- VAR-005
- Keywords
- Spinal Anesthesia, Prilocaine, Ambulatory Surgery, Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,291 participants (actual)
- Lead sponsor
- Ospedale di Circolo - Fondazione MacchiUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 9 Nov 2019 (actual)
- First posted
- 13 Nov 2019 (actual)
- 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.
The purpose of this study is to retrospectively analyze data from more than 3000 procedures, to better define the safety profile of spinal prilocaine and the incidence of complications and side effects.
Detailed description
We designed a retrospective cohort study to analyze the safety profile and the incidence of side effects associated with prilocaine for spinal anesthesia in ambulatory settings.
Data will be obtained from an internal database where are prospectively recorded clinical data from spinal anesthesia consecutively performed with prilocaine at our institution for ambulatory surgery from 2011 to 2019. Variables recorded in the database and analyzed will include demographic data, type of surgery, presence of surgical, anesthesiological or general complications, need for unplanned admission and percentage of completed database records.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Single Center Ambulatory Surgical Patients
Key inclusion criteria (1 listed)
- Ambulatory surgical procedures performed under spinal anesthesia with Prilocaine
Key exclusion criteria (2 listed)
- General Anesthesia
- Procedures lasting longer than 2 hours
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 |
|---|---|---|
| Prilocaine HydrochlorideAlso: Spinal AnesthesiaSpinal Prilocaine for Ambulatory Surgery | Drug | – |
Primary outcome
anesthesia-related complication
Time frame: 2011-2019
urinary retention, lipotimia, postoperative nausea, arrhythmia, hypotension, transient neurological symptoms, headache
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 13 Nov 2019.
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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 Anesthesia, Spinal and Prilocaine, run by Ospedale di Circolo - Fondazione Macchi 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 1 inclusion and 2 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 13 Nov 2019. 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?
anesthesia-related complication (time frame: 2011-2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2019.