A Comparison of Two Injection Locations in Obese Patients Having Lower Leg/Foot Surgery



Status:Completed
Conditions:Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2012
End Date:October 2015

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Evaluation of Ultrasound-Guided Popliteal Sciatic Nerve Blockade in the Severely and Morbidly Obese Populations

One technique for the nerve block involves injecting the numbing medicine where the nerve is
together (higher up in the back of the thigh). The other technique involves injecting the
numbing medicine where the nerve splits into two parts. By injecting numbing medication
around the nerve(s), there will be less pain after the procedure. It is thought that the
numbing medicine will be easier to inject in the group that the nerves are split. It is
expected that subjects may need less pain medication and have lower pain ratings in this
group too.

The purpose of this study is to compare two different techniques for placement of nerve
blocks for your foot or ankle procedure. A nerve block involves injecting numbing
medications around a nerve to decrease pain after surgery. An ultrasound machine is often
used to help see the nerve before injecting the numbing medicine. When an ultrasound machine
is used during a block it is called an ultrasound-guided block.

Many studies of ultrasound-guided nerve blocks have involved mostly thin patients,
especially from foreign countries. This study is different because the investigators are
looking at patients living in America with a body mass index (a measure of the amount of
body fat a person has) of more than 35.

The Sciatic nerve is a large nerve that provides most of the feeling and all of the movement
to the foot and ankle. The nerve travels under the back of the leg, and splits into two
smaller nerves slightly above the knee.

Inclusion Criteria:

- Patients ≥ 18 years of age undergoing unilateral foot and/or ankle surgery

- Severe or morbid obesity, defined as a BMI of 35-39 or ≥ 40, respectively

- ASA status I-IV

- Ability to understand and provide informed consent

Exclusion Criteria:

- True allergy, not sensitivity, to any of the following substances:

Local Anesthetics Midazolam Fentanyl Hydromorphone Propofol

- Pregnancy

- Evidence of infection at or near the proposed needle insertion site

- Unstable or undetermined neurologic disease of the lower extremity

- Chronic pain patients

- Patient refusal or inability to provide informed consent
We found this trial at
1
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New Orleans, Louisiana 70121
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New Orleans, LA
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