Onset Time of Nerve Block: A Comparison of Two Injection Locations in Patients Having Lower Leg/ Foot Surgery



Status:Completed
Conditions:Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:May 2014
End Date:March 2016

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Onset Time of Ultrasound-Guided Popliteal Sciatic Nerve Block: Comparing Circumferential Injection of Local Anesthetic to Injection That Separates the Nerve in Its Two Components

The purpose of this study is to compare injecting local anesthetic (numbing medication) in
different patterns around a major nerve in the leg. Patients who undergo surgery to the
lower leg and/or foot are usually offered the option of a nerve block to help with pain
control after surgery. A nerve block involves injecting local anesthetic (numbing medicine)
by a nerve or nerves that provide sensation to the area where surgery will be performed. The
local anesthetic (numbing medication) numbs up the area where the surgery is performed and
helps decrease the amount of pain felt after surgery. The local anesthetic (numbing
medication) can be injected in various patterns by a nerve, such as in one spot by a nerve
or completely surrounding a nerve. The local anesthetic will be either injected around the
sciatic nerve or will injected in a way that will split the sciatic nerve into the two
component nerves that make it up, the tibial and sciatic, and surrounds each nerve.

The hypothesis is that subjects in the group that local anesthetic is injected in a pattern
that separates the sciatic nerve into the two component nerves may have a faster onset time
of regional anesthesia and block success than subjects in the group that have the local
anesthetic injected at around the nerve.

After the consent form is signed, subjects will be randomly assigned (like the flip of a
coin) to either receive the local anesthestic (numbing medication) around the sciatic nerve
or in a pattern that separates the sciatic nerve into the two component nerves that make it
up, the tibial and sciatic, and surrounds each nerve.

Before the nerve block is performed, the movement and sensation in the subject's foot will
be checked to make sure it is normal. They will be asked to move their foot up and down.
Using a blunt safety needle, their foot will be gently touched in different places to see if
they can feel sharp sensations.

The amount of relaxation medication before the block will be recorded. The local anesthetic
(numbing medication) will be injected in the pattern subjects were randomly assigned. The
time it takes from the moment they are asked to say their name and birthday until they
cannot move or feel their foot will be recorded.

Five minutes from the time the injection is complete, subjects will be asked to move their
foot up and down. Also, their foot will be gently touched in different places with a blunt
safety needle to see if they can still feel sharp sensations. Subjects will be asked to do
this every five minutes until they cannot feel any sensation in their foot or if thirty
minutes pass.

A member of the study team will contact subjects by telephone in about a week to see if they
have any pain, numbness, and/or weakness in their leg/foot.

Inclusion Criteria:

- undergoing lower leg and/or foot surgery

- ASA Physical status I-III

- ability to give informed consent

- age 18 years old or older

Exclusion Criteria:

- true allergy to local anesthetics, not sensitivity, as determined by investigator

- bilateral lower extremity surgery

- patient refusal

- infection at the injection site

- peripheral neuropathy of lower extremity as documented by electromyography studies
We found this trial at
1
site
New Orleans, Louisiana 70121
?
mi
from
New Orleans, LA
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