Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty
Condition: Pain, Postoperative; Brachial Plexus Block
MeSH terms: Pain, Postoperative
Intervention: Bupivacaine HCl; Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj
Intervention description: Subjects randomized to the continuous interscalene nerve block group will receive a loading dose of 15-20 mL bupivacaine HCl 0.5% followed by a continuous catheter infusion of bupivacaine 0.2% at 8 mL per hour for 72 hours.; Subjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg).
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Unblinded
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Interscalene nerve block; total shoulder arthroplasty; pain management; OBAS; QoR-15

Summary:

      This study aims to assess analgesia efficacy between liposomal bupivacaine single injection
      interscalene blockade vs. continuous interscalene nerve block for patients undergoing primary
      total shoulder arthroplasty.
    

Eligibility criteria:

        Inclusion Criteria

          -  Adult patients with an American Society of Anesthesiologists (ASA) physiological
             status I-III

          -  Patients presenting for unilateral primary total shoulder arthroplasty (includes
             anatomic and reverse total shoulder arthroplasty).

          -  Patients 18 years of age and older

          -  Able to provide informed consent for him or herself

        Exclusion Criteria

          -  Chronic pain syndromes

          -  Chronic opioid use (>1 month) with OME >5 mg/day OR acute opioid use (< 1 month) with
             OME > 30 mg/day.

          -  Body mass index (BMI) > 45 kg/m2

          -  Severe drug allergy* to medications used in this study, including non-steroidal
             anti-inflammatory drugs (i.e. celecoxib) and local anesthetics. *defined as an immune
             reaction resulting in shortness of breath, hives, anaphylaxis, wheezing, and fever

          -  Personal or family history of malignant hyperthermia.

          -  Major systemic medical problems such as:

               -  Pre-existing severe renal disorder defined as glomerular filtration rate (GFR)
                  <50 units/m2 (if labs are available), currently on dialysis, or highly suspected
                  based on history.

               -  Severe hepatic disorder defined as current or past diagnosis of acute/subacute
                  necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis
                  (primary biliary cirrhosis), chronic hepatitis/toxic hepatitis, liver abscess,
                  hepatic coma, hepatorenal syndrome, other disorders of liver

               -  Pre-existing medical history of moderate to severe pulmonary disease requiring
                  medical therapy (obstructive and/or restrictive), use of home oxygen,
                  preoperative baseline oxygen saturation < 93% on room air.

               -  History of contralateral hemidiaphragm dysfunction (e.g., paralysis) or phrenic
                  nerve injury.

          -  Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy+ in
             the operative extremity, coagulopathy, sepsis, infection at site of injection,
             uncooperative, and refusal).

             o + pre-existing neuropathy includes sensory and/or motor deficits due to nerve insult
             of surgical extremity, radicular symptoms of surgical extremity, history of unresolved
             brachial plexus injury/brachial plexopathy, and tumors of the brachial plexus.
             Patients with nerve compression distal to site of surgery, such as history of carpal
             tunnel syndrome or cubital tunnel syndrome, are NOT considered contraindications to
             regional anesthesia.

          -  Known to be currently pregnant or actively breastfeeding++

             o ++ All surgical patients are currently screened using a standardized Pregnancy
             Assessment tool (http://mayoweb.mayo.edu/sp-forms/mc8800-mc8899/mc8801-161.pdf)

          -  Impaired cognition (e.g. Alzheimer's disease, moderate to severe dementia,
             encephalopathy)

          -  Non-English speaking