Ankle Block Versus Popliteal Fossa Block as Primary Anesthesia for Forefoot Surgical Procedures

NCT ID: NCT01376960

Last Updated: 2016-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2016-07-31

Brief Summary

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The purpose of this study is to compare, for the first time ever, single shot popliteal fossa blocks to ankle blocks as primary anesthesia for patients undergoing forefoot procedures. The primary outcome variable for this study is the percentage of patients that convert to general anesthesia following either a single shot popliteal fossa block or ankle block.

H0: There is no difference in the percentage of patients that convert to general anesthesia between single shot popliteal fossa blocks and ankle blocks.

HA: There will be a lower percentage of patients receiving a single shot popliteal fossa block that convert to general anesthesia compared to patients receiving an ankle block.

Detailed Description

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Conditions

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Anesthesia Forefoot Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single shot popliteal fossa block

Group Type ACTIVE_COMPARATOR

elective forefoot surgery

Intervention Type PROCEDURE

Includes both soft-tissue and osseous procedures.

ankle blocks

Group Type ACTIVE_COMPARATOR

elective forefoot surgery

Intervention Type PROCEDURE

Includes both soft-tissue and osseous procedures.

Interventions

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elective forefoot surgery

Includes both soft-tissue and osseous procedures.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing elective forefoot surgery, including both soft-tissue and osseous procedures

Exclusion Criteria

* Diabetes
* Any form of Peripheral neuropathy
* Known allergy to local anesthesia
* Active infection
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OrthoCarolina Research Institute, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruce E Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

OrthoCarolina, PA

Locations

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OrthoCarolina, PA

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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121809A

Identifier Type: -

Identifier Source: org_study_id

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