NCT02406703

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

March 30, 2015

Last Update Submit

March 9, 2020

Conditions

Keywords

local anesthesiaregional anesthetic

Outcome Measures

Primary Outcomes (1)

  • Cost minimization analysis

    6 months

Study Arms (2)

Chloroprocaine

Patient undergoing popliteal block with chloroprocaine

Drug: Chloroprocaine

Mepivacaine

Patient undergoing popliteal block with mepivacaine

Drug: Mepivacaine

Interventions

Chloroprocaine
Mepivacaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

chloroprocaineMepivacaine

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 2, 2015

Study Start

January 1, 2014

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

March 11, 2020

Record last verified: 2020-03