Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:12/13/2018
Start Date:October 29, 2018
End Date:September 2019

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Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty: A Single Blinded Prospective Randomized Control Trial

The objective of this study is to determine if peripheral nerve block with liposomal
bupivacaine in combination with standard bupivacaine will prolong the duration of block,
improve pain scores, and decrease opioid utilization in the post-operative period when
compared to peripheral nerve block with standard bupivacaine alone.

This is a prospective, single-blinded randomized clinical trial comparing outcomes in
patients undergoing total shoulder arthroplasty (anatomic and reverse) who receive a
peripheral nerve block with liposomal bupivacaine in combination with standard bupivacaine
versus standard bupivacaine alone. Once consent is obtained, baseline characteristics will be
recorded and patients will be randomized to intervention or control. Following surgery,
patients will be followed until their 3-week post-operative visit. The primary outcome
measure will be the mean difference in patient pain scores over the first 72 hours
post-operatively between two groups. Secondary outcomes will include: (1) Total opioid
consumption (as measured utilizing morphine intravenous equivalents) in first 72 hours and at
3 weeks (2) Patient perceived duration of block determined as the time patient perceives
complete resolution of block (3) Patient satisfaction with pain control at 72 hours, 3 weeks
post-operatively and patient reported outcome measures (SANE, SST, ASES, VR-12) at 3 weeks
post-operatively.

Inclusion Criteria

- All adult patients (>18 years of age)

- Patients undergoing standard or reverse total shoulder arthroplasty for the primary
diagnoses of glenohumeral arthritis or cuff tear arthropathy

- Cognitively intact with the ability to give informed consent as outlined by our
institutional review board.

- Patients must be capable of participating in the post-operative electronic survey and
/ or able to maintain a written diary of events

Exclusion Criteria

- Non-elective cases

- Infection, tumor, trauma

- Weight < 50 kg

- Patients with any contraindications to regional anesthesia including allergy or
hypersensitivity to amide-type local anesthetics

- Patients with allergy to any component of medication regimen e.g. amide- type local
anesthetics, oxycodone, hydromorphone, fentanyl

- Chronic pain patients with history of chronic opioid use (defined as 20 mg morphine
equivalent / day for greater than 30 days pre-operatively

- Concurrent painful physical condition that may require analgesic treatment that is not
related to the shoulder surgery (chronic peripheral neuropathy, radiculopathy, or
other neurologic disorder)

- Severe hepatic disease defined by clinical evidence of liver disease with abnormal
liver function tests.

- Pregnancy

- Respiratory disease that contraindicates interscalene nerve block (elevated
contralateral hemidiaphragm, contralateral pneumonectomy, or severe COPD with FEV1 <
50% predicted, and 02 dependence)
We found this trial at
1
site
Phoenix, Arizona 85054
Phone: 480-342-6487
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mi
from
Phoenix, AZ
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