The Impact of Chloroprocaine 3% for Ambulatory Foot Surgery on Perioperative Process Costs

March 9, 2020 updated by: Andrea Saporito, Ospedale Regionale Bellinzona e Valli

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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)

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chloroprocaine
Patient undergoing popliteal block with chloroprocaine
Mepivacaine
Patient undergoing popliteal block with mepivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cost minimization analysis
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

March 30, 2015

First Submitted That Met QC Criteria

April 1, 2015

First Posted (Estimate)

April 2, 2015

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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