Exparel Interscalene vs Indwelling Catheter



Status:Not yet recruiting
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:40 - 74
Updated:2/3/2019
Start Date:February 15, 2019
End Date:April 29, 2019
Contact:Roman Margulis, MD
Email:romargul@montefiore.org
Phone:6465291190

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Prospective Randomized Control Trial Evaluating Single Shot Exparel Versus Indwelling Interscalene Catheter for Total Shoulder Replacements- A Pilot Study

The investigators are comparing an indwelling catheter with intermediate duration local
anesthetic to a single shot peripheral nerve block with long acting a local anesthetic
(Exparel).

While placing an indwelling nerve catheter can prolong pain control, it can also have
drawbacks and complications. While major complications like pneumothorax and
hemidiaphragmatic paresis from interscalene continuous peripheral nerve blocks (CPNB) are
rare, minor adverse effects associated with CPNBs may be more common. They include infection
and anatomical damage to blood vessels and nerves due to the indwelling catheter. In
addition, catheters take a significantly longer time to set up and place than single shot
blocks, which is important as there is often a rush to block patients and trying to get them
into the operating room on time. Furthermore, the needle used for catheter placement is
larger than the single shot needles, which creates more discomfort to patients during the
nerve block. The catheter itself is taped around the entire sides and back of the patient's
neck, which is also uncomfortable for patients. Because of how shallow the interscalene block
is, the catheter is often found to be dislodged from operating room positioning, patient
transport or movement, which negates the placement of the catheter. An indwelling catheter
must also be followed up by the acute pain service team until the catheter is removed.

Exparel, or liposomal bupivacaine, is formulated to release low dose bupivacaine over 96
hours, and was recently approved by the FDA in April 2018 to be used in interscalene blocks.
The sustained release of local anesthetic could theoretically act similarly to the continuous
infusion of local anesthetic through an indwelling interscalene catheter, and could thus
avoid the need for placement of a catheter. Current existing data, although inconclusive, has
in some studies shown an equal analgesic effect as catheters. As per pharmacy, the cost of
the On-Q pump and the local anesthesia needed for the pump together cost $390 for each
indwelling catheter placed, not including the cost of anesthesia and pharmacy supplies and
labor. The cost of each 20 mL vial of Exparel is less at $285 and, for a single shot nerve
block, would avoid the extra costs and time needed for a catheter placement.

The investigators would like to perform a prospective randomized controlled pilot study to
examine the efficacy of single shot interscalene blocks using Exparel versus the traditional
interscalene catheter used at our institution. The purpose of the study the investigators are
proposing is to determine if single shot interscalene nerve blocks using Exparel can provide
equivalent or better analgesia than indwelling interscalene catheter in patients who undergo
total shoulder replacement surgery. If so, single shot interscalene nerve blocks with Exparel
may serve as a quicker, easier, cheaper, safer, and more comfortable alternative to placing
indwelling interscalene catheters.

Inclusion Criteria:

- American Society of Anesthesia (ASA) 1, 2, and 3

- Ages 40-74

- Patients scheduled for total shoulder replacement

Exclusion Criteria:

- ASA 4 and 5

- Pre-existing pain disorder

- Regular consumption of chronic pain medication

- pregnant women

- any medical condition such as a clotting disorder

- anatomic abnormality that precludes use of an indwelling scalene catheter

- Body Mass Index (BMI) >40

- Patient refusal

- Pre-existing diabetic neuropathy or Hemoglobin A1c >9

- Failed block
We found this trial at
1
site
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Roman Margulis, MD
Phone: 646-529-1190
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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mi
from
Bronx, NY
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