NCT00699244

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

June 12, 2017

Status Verified

June 1, 2017

Enrollment Period

2.1 years

First QC Date

June 12, 2008

Last Update Submit

June 9, 2017

Conditions

Hand SurgeryElbow SurgeryForearm SurgeryWrist Surgery

Keywords

forearmhandelbowwristbrachial plexusinfraclavicular block

Outcome Measures

Primary Outcomes (1)

  • increase success rate of the block to produce surgical anesthesia and analgesia

    during and following surgical procedure

Study Arms (2)

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

Peripheral placement of local anesthesiaPROCEDURE

Peripheral placement of local anesthesia

Peripheral placement of local anesthesia
Central placement of local anesthesiaPROCEDURE

Central placement of local anesthesia

Central placement of local anesthesia

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Orthopedic Surgicenter

Nashville, Tennessee, 37212, United States

Location

Related Links

Study Officials

  • Clifford Bowens, M.D.

    clifford.bowens@vanderbilt.edu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 12, 2008

First Posted

June 17, 2008

Study Start

December 1, 2006

Primary Completion

January 1, 2009

Study Completion

March 1, 2009

Last Updated

June 12, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)