Evaluation of Second Esmarch Application on Intravenous Regional Anesthesia Effectiveness



Status:Recruiting
Conditions:Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - 100
Updated:10/13/2018
Start Date:July 1, 2017
End Date:June 2020
Contact:Tolga Turker, MD
Email:tturker@ortho.arizona.edu
Phone:(520) 626-4024

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Intravenous regional anesthesia is a commonly used technique in the outpatient setting for
short hand and upper extremity cases, such as carpal tunnel release or trigger finger
release. The technique requires a tourniquet, Esmarch bandage, an intravenous line, and
lidocaine. It can be performed and learned easily. The technique is safe and easy to perform,
and it provides adequate anesthesia for short cases; however, there are still some cases in
which adequate anesthesia is not achieved. One of the possible reasons for failure is that
the local anesthetic (lidocaine) does not properly exit the veins to reach the interstitial
space (where many nerves are located) to provide the nerve block. In this study, the
investigators hypothesize that after application of lidocaine to the intravenous system,
application of external pressure through the skin will facilitate tissue penetration and
improve the block. The only research procedure being done is a re-application of the Esmarch
bandage; all other procedures are Standard of Care.

Intravenous regional anesthesia (IVRA), also known as Bier block, is a technically simple and
reliable technique for achieving anesthesia for short surgical procedures. It is performed by
injecting a local anesthetic (usually lidocaine) intravenously in the setting of a double
tourniquet on the upper arm which limits the anesthetic effect to that portion of the body to
avoid systemic effects. This technique is suitable for short procedures on the forearm and
the hand with minimal complications. Variations of the technique alter the location of the
tourniquet, the volume of local anesthetic, or the addition of additional anesthetic agents
in an effort to provide the best anesthesia. Despite these variations, the block may still
fail. Some studies show a success rate of 94-98% while others show a success rate of 78.1%
depending on the definition of success (usually defined by whether or not additional
anesthesia was necessary during the surgery). In general, however, IVRA has a high success
rate. This study aims to improve the success rate (defined by no additional anesthetic needs
during surgery) of IVRA by slightly modifying the IVRA protocol. This modification is
described in greater detail below (in the research procedures section), but in essence one of
the steps involved in the IVRA procedure is to apply an elastic bandage (Esmarch bandage) to
the upper extremity to achieve exsanguination before inflating the double tourniquet. The
only modification the investigators are making in this study is to reapply the Esmarch
bandage in the exact same fashion after the anesthetic has been injected intravenously. This
reapplication of the bandage is not for exsanguination but instead for promoting anesthetic
extravasation into the interstitial space. Studies show that the main site of action for IVRA
is in the interstitial space where small nerve endings and nerve trunks are located. The
modification proposed in this study hopes to improve extravasation of the local anesthetic
from the venous system into the interstitial space where it will be better able to function.
In this study the investigators hope to compare success rates of the standard technique of
IVRA to our method in which the investigators reapply the Esmarch bandage soon after
injecting local anesthetic intravenously for short hand and upper extremity cases.

Two groups of human subjects with similar demographics will be used for this research: 40
patients randomly assigned to the control group and 40 patients randomly assigned to the
study group. The REDCap randomization module will be used for the randomization process, and
this process will take place in clinic on the day the patient is recruited and consented. For
patients willing to be part of the study, it will be made absolutely clear to them during the
consent process that there is a chance they will be assigned to the control group.

In the pre-operative area on the day of the procedure, patients will be reminded of their
voluntary participation in the study (and their ability to withdraw at any time before or
after the surgery). At this time the individual who initially recruited/consented the patient
(e.g. Dr. Turker or Dr. Morin, henceforth "surgeon") will have the patient fill out the
demographic information portion of the Bier Block Research Data Collection Form which
includes the following: date of birth, sex, BMI, forearm circumference measured at greatest
circumference, and comorbidities. Next, the surgeon will fill out the procedure information
section of the data collection form which includes the following: date of the procedure, name
of the surgeon, name of the anesthesiologist, name of the procedure, and the side of the
procedure. At this point the patient may proceed to surgery.

Intravenous anesthesia will be performed using a tourniquet, Esmarch bandage, an intravenous
line, and lidocaine diluted with normal saline. First, intravenous access will be obtained on
the surgical side, preferably on the dorsum of the hand (however it is standard procedure to
try the wrist or forearm if adequate intravenous access cannot be achieved on the dorsum of
the hand). Then, a double tourniquet will be applied to the upper arm. An Esmarch bandage
will be applied from the fingertips to the tourniquet with protection of the intravenous
line. The distal cuff of the tourniquet will then be inflated to 250-300 mmHg. The proximal
cuff will be immediately inflated to the same pressure and the Esmarch bandage will be
removed. The patient's radial pulse will be checked and the surgeon will then assess the arm
for adequate exsanguination prior to injection of 0.5-1% lidocaine, 25-50 milliliters,
depending on patient size and anesthesiologist choice. At this point, if the patient was
randomized to the study group, the Esmarch bandage will then be applied again in the exact
same fashion as above and then immediately removed (this is the ONLY research portion of the
study). If the patient was randomized to the control group, the reapplication of the Esmarch
bandage will be skipped. Next, the distal cuff will be deflated and the intravenous line on
the surgical side will be removed. Standard surgical preparation will commence while the Bier
block sets up. If the patient experiences tourniquet pain, the distal cuff will be inflated
and the proximal cuff will be deflated. The time to adequate block will be recorded on the
data collection form once the patient is no longer able to feel sharp sensation (typically
tested by gently poking skin with a sharp surgical instrument). If at any point during the
surgery the patient requires additional anesthesia to control pain, the Bier block will be
considered a failure. Once adequate pain control is achieved, the surgery proceeds in the
usual fashion. Only cases lasting less than 45 minutes will be included in the study. The
remainder of the data collection form will be filled out by the surgeon at the end of the
procedure and includes the following information: tourniquet time/pressure, block
success/failure, blood pressure at time of tourniquet, whether the Esmarch was applied twice,
anesthesia type/dose, anatomical IV placement, complications, and additional anesthesia
requirements. These completed data collection forms will then be immediately stored in a
locked cabinet in the Human Movement Biomechanics Lab (B103). Every week these forms will be
transferred to REDCap, and the hard copies will be destroyed securely.

To reiterate and emphasize, the reapplication of the Esmarch bandage is the only research
procedure. All other procedures are standard of care. This step may improve the time to
adequate block and quality of anesthesia.

After the data from each of the 80 patients' collection forms have been transferred to
REDCap, the research team will review and statistically analyze the data. The duration of
participation for patients is the length of surgery (in operating room time).

Inclusion Criteria:

- Male and female patients aged 18-100.

- Short upper extremity or hand surgery (cases lasting less than 45 minutes).

- Must be outpatient surgery.

Exclusion Criteria:

- Patients requesting to withdraw from the study.

- Patients with a history of drug abuse or illicitly used controlled drugs or substances
within the last year.
We found this trial at
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Tucson, Arizona 85721
(520) 621-2211
Phone: 520-626-4024
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