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

• Sponsor: Ospedale Regionale Bellinzona e Valli (Other)
• Overall Status: Completed
• CT.gov ID: NCT02406703
• Collaborator: (none)
• Enrollment: 100
• Actual Duration (Months): 3.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Impact of Anesthetic Choice on Costs	Drug: Chloroprocaine; Drug: Mepivacaine

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Chloroprocaine Patient undergoing popliteal block with chloroprocaine	Drug: Chloroprocaine
Mepivacaine Patient undergoing popliteal block with mepivacaine	Drug: Mepivacaine

Outcome Measures

Primary Outcome Measures

1. Cost minimization analysis [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ospedale Regionale Bellinzona e Valli

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andrea Saporito, MD, Ospedale Regionale Bellinzona e Valli
• ClinicalTrials.gov Identifier: NCT02406703
• Other Study ID Numbers: BLV07
• First Posted: Apr 2, 2015
• Last Update Posted: Mar 11, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Andrea Saporito, MD, Ospedale Regionale Bellinzona e Valli: local anesthesia; regional anesthetic
• Additional relevant MeSH terms: Mepivacaine; Chloroprocaine

Study Results

No Results Posted as of Mar 11, 2020