Interscalene Block With and Without Liposomal Bupivacaine in Shoulder Surgery



Status:Recruiting
Conditions:Post-Surgical Pain, Orthopedic
Therapuetic Areas:Musculoskeletal, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:12/14/2018
Start Date:November 21, 2018
End Date:August 30, 2019
Contact:Paul M Sethi, MD
Email:sethi@onsmd.com
Phone:(203) 869-1145

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The purpose of this study is to examine the difference in perioperative pain after shoulder
surgery with a standard bupivacaine nerve block compared to liposomal bupivacaine enhanced
nerve block alone in TSA and ARCR. Data will be compared using VAS scores and opiate
consumption between the two groups. The hypothesis of this study is that an interscalene
nerve block with liposomal bupivacaine will decrease both postoperative VAS pain scores and
total narcotic consumption when compared to a standard bupivacaine interscalene nerve block
alone.

Arthroscopic rotator cuff repair (ARCR) and shoulder arthroplasty (TSA) provide excellent
clinical outcomes but are often associated with significant postoperative pain, frequently
managed with oral opioid medication. Orthopedic surgeons prescribe approximately 32 unused
pills per shoulder surgery and are the third largest prescribers of opiates in the USA. It is
incumbent upon the orthopedic community to identify postoperative pain management methods
which reduce the need for narcotic medication following shoulder procedures as a means to
mitigate the impact of orthopedic procedures on this epidemic.

The use of intraoperative local and regional anesthesia or field blocks, in conjunction with
multimodal pharmacological strategies, is an accepted approach for managing surgical pain and
reducing opiate use but requires peer reviewed protocols to gain wider acceptance.

Interscalene nerve block with bupivacaine remains a gold standard for peri-operative
analgesia, but is associated with significant rebound pain due to the short duration of the
local anesthetics. Recent studies have demonstrated that the addition of a liposomal
bupivacaine field block may lower pain and enhance patient satisfaction throughout the first
postoperative week. Liposomal bupivacaine has recently received FDA approval for ISB, but the
data regarding its efficacy in nerve blocks is sparse.

The purpose of this pilot study is to determine if liposomal bupivacaine-enhanced
interscalene nerve blocks can be used to improve peri-operative pain control methods, limit
narcotic use, and provide appropriate postoperative analgesia compared to standard
bupivacaine blocks. Primary and secondary outcome measures will be collected as number of
opiates taken and self-reported VAS pain scores over a 14 day postoperative period,
respectively.

The hypothesis of this study is that an interscalene nerve block with liposomal bupivacaine
will decrease both postoperative VAS pain scores and total narcotic consumption when compared
to a standard bupivacaine interscalene nerve block alone.

Inclusion Criteria:

- Patients over 18 undergoing rotator cuff repair or total shoulder arthroplasty

Exclusion Criteria:

- Pregnant

- Documented drug of alcohol abuse

- Active narcotic use prior to surgery

- Neurological deficit

- Allergy to amide anesthetics

- Not cleared by primary care physician

- Hydrocodone or oxycodone intolerance

- Enrollment in another clinical trial or past cognitive or mental health status that
interferes with study
We found this trial at
6
sites
Atlantis, Florida 06831
Principal Investigator: Howard D Routman, DO
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Atlantis, FL
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Greenwich, Connecticut 06830
Principal Investigator: Paul M Sethi, MD
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from
Greenwich, CT
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Greenwich, Connecticut 06831
Principal Investigator: Paul M Sethi, MD
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from
Greenwich, CT
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Medford, Oregon 97504
Principal Investigator: Patrick J Denard, MD
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from
Medford, OR
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900 Village Square Crossing
Palm Beach Gardens, Florida 33410
Principal Investigator: Howard D Routman, DO
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from
Palm Beach Gardens, FL
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Stamford, Connecticut 06902
Principal Investigator: Paul M Sethi, MD
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from
Stamford, CT
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