Comparison of Central Versus Peripheral Placement of Local Anesthetic

Sponsor

Vanderbilt University (Other)

Overall Status

Completed

CT.gov ID

NCT00699244

Collaborator

(none)

218

Enrollment

Location

Arms

Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hand Surgery Elbow Surgery Forearm Surgery Wrist Surgery	Procedure: Peripheral placement of local anesthesia Procedure: Central placement of local anesthesia	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

218 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Selective Local Anesthetic Placement Using Ultrasound-guidance and Neurostimulation for the Infraclavicularbrachial Plexus Block

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Peripheral placement of local anesthesia to receive ultrasound guided peripheral placement of local anesthetic	Procedure: Peripheral placement of local anesthesia Peripheral placement of local anesthesia
Active Comparator: Central placement of local anesthesia to receive central placement of local anesthetic	Procedure: Central placement of local anesthesia Central placement of local anesthesia

Arm

Intervention/Treatment

Experimental: Peripheral placement of local anesthesia

to receive ultrasound guided peripheral placement of local anesthetic

Procedure: Peripheral placement of local anesthesia

Peripheral placement of local anesthesia

Active Comparator: Central placement of local anesthesia

to receive central placement of local anesthetic

Procedure: Central placement of local anesthesia

Central placement of local anesthesia

Outcome Measures

Primary Outcome Measures

increase success rate of the block to produce surgical anesthesia and analgesia [during and following surgical procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.