Comparison of Central Versus Peripheral Placement of Loca... | NCT00699244

Studies
Comparison of Central Versus Peripheral Placement of Local Anesthetic

NCT00699244

Sponsor

Vanderbilt University

Status

Completed

Last Update Posted

Jun 12, 2017Actual

Enrollment

218Actual

Phase

Not Applicable

Conditions

Hand Surgery
Elbow Surgery
Forearm Surgery
Wrist Surgery

Interventions

Peripheral placement of local anesthesia
Central placement of local anesthesia

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

Jun 2017

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

Dec 2006

Primary Completion Date

Jan 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Jun 12, 2008

First Submission Date that Met QC Criteria

Jun 12, 2008

First Posted Date

Jun 17, 2008Estimated

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

Jun 9, 2017

Last Update Posted Date

Jun 12, 2017Actual

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

Does ultrasound increases the success rate and if there is a difference in success rate between placing the local anesthetic centrally versus peripherally.

Detailed Description

A comparison of the infraclavicular placement of local anesthetic either centrally (posterior cord) vs peripheral placement (lateral or medial cord) using ultrasound guidance. This will be done to determine if ultrasound increases the success rate and if there is a difference in success rate between placing the local anesthetic centrally versus peripherally.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

218Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Peripheral placement of local anesthesia	Experimental	to receive ultrasound guided peripheral placement of local anesthetic	Procedure: Peripheral placement of local anesthesia
Central placement of local anesthesia	Active Comparator	to receive central placement of local anesthetic	Procedure: Central placement of local anesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peripheral placement of local anesthesia	Procedure	Peripheral placement of local anesthesia	Peripheral placement of local anesthesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
increase success rate of the block to produce surgical anesthesia and analgesia		during and following surgical procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologists (ASA) Class I-III.
Patient is undergoing elective hand or forearm surgery.
Patient is an adult, 18 years old or older.

Exclusion Criteria:

Morbid obesity (calculated body mass index > 35 kg/m2).
Patient unable to cooperate.
Patient with a known brachial plexus injury.
Medical contraindication to anesthetic technique (allergy, cardiac condition, neurologic condition, localized infection, bleeding disorder).
Patients who are pregnant.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clifford Bowens, M.D.	clifford.bowens@vanderbilt.edu	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Orthopedic Surgicenter		Nashville	Tennessee	37212	United States

References Module

Citations

Not provided