Impact of Anesthetic Choice on CostsNCT02406703
The Impact of Chloroprocaine 3% for Ambulatory Foot Surgery on Perioperative Process Costs
An observational study of Impact of Anesthetic Choice on Costs, run by Ospedale Regionale Bellinzona e Valli.
Trial summary
Background and Objectives Short acting regional anesthetics have already been successfully employed for peripheral nerve blocks in an ambulatory surgery setting. However, the impact on direct and indirect perioperative costs comparing two different short-acting local anesthetics has not been performed, yet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Impact of Anesthetic Choice on Costs
- What is being tested?
- Chloroprocaine and Mepivacaine
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to May 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ASA I-III scheduled for elective, unilateral, ambulant minor foot surgery (percutaneous hallux valgus correction, osteotomies, tenotomies, mallet and hammer toes correction, screws and/or plaques removal)
Who may be able to join
- ASA I-III scheduled for elective, unilateral, ambulant minor foot surgery (percutaneous hallux valgus correction, osteotomies, tenotomies, mallet and hammer toes correction, screws and/or plaques removal)
Who cannot join
- known allergy to drugs used in the study;
- coagulopathies, known neuropathy;
- pregnancy;
- chronic pain;
- drug or alcohol abuse;
- psychiatric disease or lack of competence affecting compliance and evidence of ongoing sepsis or local skin / subcutaneous tissues infections in the popliteal fossa.
About this study
Official title: Can the Choice of the Local Anesthetic Have an Impact on Ambulatory Surgery Perioperative Costs? Chloroprocaine for Popliteal Block in Outpatient Foot Surgery
Background and Objectives Short acting regional anesthetics have already been successfully employed for peripheral nerve blocks in an ambulatory surgery setting. However, the impact on direct and indirect perioperative costs comparing two different short-acting local anesthetics has not been performed, yet.
Methods In an observational study including 50 patients per group, patient undergoing popliteal block with chloroprocaine 3% or mepivacaine 1.5% for ambulatory minor foot surgery were compared. The primary outcome was the saving of both direct and indirect perioperative costs. Secondary outcomes were block success, onset time and block duration, patient satisfaction and unplanned outpatient visits or readmissions after discharge.
- Conditions
- Impact of Anesthetic Choice on Costs
- Being tested
- Chloroprocaine, Mepivacaine
- Keywords
- local anesthesia, regional anesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloroprocaineDrug
MepivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Chloroprocaine | Patient undergoing popliteal block with chloroprocaine Receives: Drug: Chloroprocaine | |
| Mepivacaine | Patient undergoing popliteal block with mepivacaine Receives: Drug: Mepivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost minimization analysis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startJan 2014
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impact of Anesthetic Choice on CostsStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Regionale Bellinzona e Valli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Saporito, Ospedale Regionale Bellinzona e Valli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406703
- Sponsor's protocol ID
- BLV07
- Status last verified
- Mar 2020
- First submitted
- 30 Mar 2015
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Choice of the Local Anesthetic Have an Impact on Ambulatory Surgery Perioperative Costs? Chloroprocaine for Popliteal Block in Outpatient Foot Surgery
- ClinicalTrials.gov ID
- NCT02406703
- Acronym / sponsor ID
- BLV07
- Conditions
- Impact of Anesthetic Choice on Costs
- Keywords
- local anesthesia, regional anesthetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ospedale Regionale Bellinzona e ValliUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 Apr 2015 (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.
Background and Objectives Short acting regional anesthetics have already been successfully employed for peripheral nerve blocks in an ambulatory surgery setting. However, the impact on direct and indirect perioperative costs comparing two different short-acting local anesthetics has not been performed, yet.
Methods In an observational study including 50 patients per group, patient undergoing popliteal block with chloroprocaine 3% or mepivacaine 1.5% for ambulatory minor foot surgery were compared. The primary outcome was the saving of both direct and indirect perioperative costs. Secondary outcomes were block success, onset time and block duration, patient satisfaction and unplanned outpatient visits or readmissions after discharge.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chloroprocaine | – | Drug: ChloroprocainePatient undergoing popliteal block with chloroprocaine |
| Mepivacaine | – | Drug: MepivacainePatient undergoing popliteal block with mepivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ASA I-III scheduled for elective, unilateral, ambulant minor foot surgery (percutaneous hallux valgus correction, osteotomies, tenotomies, mallet and hammer toes correction, screws and/or plaques removal)
Key inclusion criteria (1 listed)
- ASA I-III scheduled for elective, unilateral, ambulant minor foot surgery (percutaneous hallux valgus correction, osteotomies, tenotomies, mallet and hammer toes correction, screws and/or plaques removal)
Key exclusion criteria (6 listed)
- known allergy to drugs used in the study;
- coagulopathies, known neuropathy;
- pregnancy;
- chronic pain;
- drug or alcohol abuse;
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 |
|---|---|---|
| Chloroprocaine | Drug | Chloroprocaine |
| Mepivacaine | Drug | Mepivacaine |
Primary outcome
Cost minimization analysis
Time frame: 6 months
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 11 Mar 2020.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Impact of Anesthetic Choice on Costs, run by Ospedale Regionale Bellinzona e Valli.
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 6 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 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Cost minimization analysis (time frame: 6 months). 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 11 Mar 2020.