LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs
Condition: Post-operative Pain; Total Shoulder Arthroplasty; Osteoarthritis of the Shoulder; Pain Management
MeSH terms: Pain, Postoperative
Intervention: Liposomal Bupivicaine 1.3%; Bupivacaine 0.5%
Intervention description: 10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block; 20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
Intervention MeSH terms: Dexamethasone; Epinephrine; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-center, prospective, randomized controlled cross-sectional study
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Brachial Plexus; Liposomal Bupivacaine; Dexamethasone; Interscalene; Bupivacaine; Shoulder Arthroplasty; Regional anesthesia; Exparel

Summary:

      This will be a single-center, prospective, randomized controlled cross-sectional study
      comparing interscalene brachial plexus block with liposomal bupivacaine versus bupivacaine
      with epinephrine and PF dexamethasone in patients undergoing primary shoulder arthroplasty.
      Primary endpoint will be total opioid consumption in the first three post-operative days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient age >18 years;

          -  Lack of language barrier;

          -  Informed consent obtained;

          -  Presenting for primary total shoulder arthroplasty (TSA), both anatomic and reverse,
             by a specialty-trained surgeon;

          -  American Society of Anesthesiology (ASA) physical status score I- III

        Exclusion Criteria:

          -  Presence of a language barrier;

          -  Inability to complete telephone and/or paper questionnaire;

          -  Lack of consent;

          -  Allergy to local anesthetic;

          -  Chronic pain syndrome and/or preoperative opioid use > 50 MME per day (including
             extended-release formulations and methadone);

          -  Preoperative consultation to chronic pain service;

          -  History of (<3 months) or current substance abuse, including any illicit drugs or
             excessive alcohol consumption as defined by the Office of Disease Prevention and
             Health Promotion (4 or more drinks per day or 8 or more drinks per week for women and
             5 or more drinks per day or 15 or more drinks per week for men);

          -  Baseline peripheral neuropathy of the brachial plexus;

          -  Contraindication to receiving single shot peripheral nerve blockade; including
             antithrombotic medications as per most recent American Society of Regional - -
             -Anesthesiology (ASRA) guidelines 17 , coagulopathy or coagulation disorder, or
             infection at injection site;

          -  Severe chronic obstructive pulmonary disease (COPD) or other significant pulmonary
             disease where interscalene nerve block would be contraindicated due to concern for
             respiratory failure from phrenic nerve palsy;

          -  Weight < 45 kg, given concern for local anesthetic toxicity at dosages given for the
             study; ASA score IV-V;

          -  Revision arthroplasty;

          -  Anatomic abnormality that limits or prevents the patient from receiving an
             interscalene nerve block;

          -  Pregnant, nursing, or planning to become pregnant during the study or within 1 month
             after the shoulder replacement surgery