Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty
Condition: Arthropathy Shoulder
MeSH terms: Joint Diseases
Intervention: Liposomal Bupivacaine; Bupivacaine Hydrochloride
Intervention description: Interscalene Nerve Blocks; Interscalene Nerve Blocks
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The pharmacist will prepare, and dispense the medication sequentially. Medication syringes will be blinded utilizing black tape. Patients, care team in recovery, study team members collecting and recording data, and statisticians will be blinded to randomization assignment. All patients will be documented in EMR as receiving liposomal bupivacaine to ensure the blind is maintained and to ensure that safety features in the EMR for all patients receiving liposomal bupivacaine are activated. Further, all additional standard precautionary measures (e.g. wrist band) will be similarly implemented for both patient groups.
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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)