Ankle Block Versus Popliteal Fossa Block as Primary Anest... | NCT01376960

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

NCT01376960

Sponsor

OrthoCarolina Research Institute, Inc.

Status

Completed

Last Update Posted

Aug 22, 2016Estimated

Enrollment

202Actual

Phase

Phase 4

Conditions

Anesthesia
Forefoot Surgery

Interventions

elective forefoot surgery

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Jan 2015Actual

Completion Date

Jul 2016Actual

First Submitted Date

Jul 29, 2009

First Submission Date that Met QC Criteria

Jun 17, 2011

First Posted Date

Jun 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2016

Last Update Posted Date

Aug 22, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

202Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
single shot popliteal fossa block	Active Comparator		Procedure: elective forefoot surgery
ankle blocks	Active Comparator		Procedure: elective forefoot surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
elective forefoot surgery	Procedure	Includes both soft-tissue and osseous procedures.	ankle blocks single shot popliteal fossa block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Conversion to general anesthesia following either a single shot popliteal fossa block or ankle block	Popliteal fossa and ankle blocks are types of anesthesia used during surgery. If these methods are not effective as an anesthetic during surgery the anethesiologist will convert to general anesthesia.	Participants will be followed for the duration of the surgery, an expected average of 2 hours

Secondary Outcomes

Measure	Description	Time Frame
Visual Analog Pain Scale (VAS)		24 hours postoperatively
Patient Satisfaction		48 hours postoperative
Length of Post Anesthesia Care Unit (PACU) stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bruce E Cohen, MD	OrthoCarolina, PA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OrthoCarolina, PA		Charlotte	North Carolina	28203	United States