Analgesic Efficacy of Interscalene Nerve Block Versus Local Infiltration Analgesia Following Total Shoulder Arthroplasty
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Single shot interscalene nerve block; Continuous interscalene nerve block; Local Infiltration Analgesia (LIA)
Intervention description: Peripheral regional anesthesia nerve block - Single shot interscalene nerve block; Peripheral regional anesthesia nerve block - continuous catheter interscalene nerve block; Injection of local anesthetic into the peri-articular tissues and intra-articular capsule in a systematic approach for orthopedic surgery
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Nerve Block/methods; Pain, Postoperative/prevention & control; Anesthetics, Local/administration & dosage; Brachial Plexus/ultrasonography; Shoulder Pain/prevention & control

Summary:

      Total shoulder arthroplasty (TSA) is considered to be a major surgical procedure resulting in
      severe postoperative pain, especially in the first 48 hours after surgery. The use of
      interscalene brachial plexus nerve block remains the cornerstone for analgesia following
      shoulder surgery; however, with the advent of local infiltration analgesia (LIA), there has
      been increasing interest in its use for total joint arthroplasty.

      Since the benefits of local infiltration analgesia within a comprehensive multi-modal
      analgesia clinical pathway have yet to be established for total shoulder arthroplasty, the
      Investigators plan to assess and compare analgesia outcomes between three intervention
      groups: single shot interscalene brachial plexus block (SISB), continuous interscalene
      brachial plexus block (CISB), and local infiltration analgesia (LIA).
    

Eligibility criteria:

        Inclusion criteria:

          1. Adult patients with an American Society of Anesthesiologists (ASA) physiological
             status I-III

          2. Patients presenting for unilateral primary total shoulder arthroplasty (includes
             anatomic and reverse total shoulder arthroplasty).

          3. Patients 18 years of age and older

          4. Able to provide informed consent for him or herself

        Exclusion Criteria:

          1. Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome

          2. Chronic opioid use (>1 mos) with oral morphine equivalents (OME) >5 mg/day OR acute
             opioid use (< 1 mos) with OME > 30 mg/day.

          3. Body mass index (BMI) > 45 kg/m2

          4. Severe drug allergy* to medications used in this study, including non-steroidal
             anti-inflammatory drugs (i.e. celecoxib and ketorolac), and local anesthetics.

          5. History of Malignant Hyperthermia.

          6. 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 (obstructive
                  and/or restrictive), use of home oxygen, preoperative baseline oxygen saturation
                  < 94% on room air, forced expiratory volume in 1 second (FEV 1) < 60% of
                  predicted value (obstructive disease), vital capacity (VC) or total lung capacity
                  (TLC) < 70% predicted value (restrictive disease).37

               -  History of contralateral hemidiaphragmatic dysfunction (e.g., paralysis) or
                  phrenic nerve injury.

          7. Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy+ in
             the operative extremity, coagulopathy, sepsis, infection at site of injection,
             uncooperative, refusal, anticoagulation medications not held within appropriate time
             frame per American Society of Regional Anesthesia (ASRA) guidelines.

          8. Previous contralateral total shoulder replacement managed with regional anesthetic
             nerve block or periarticular injection/intraarticular injection within the previous 12
             months.

          9. Known to be currently pregnant or actively breastfeeding++

             • ++ Patients that have a previous history of menopause, hysterectomy, or tubal
             ligation will not be required to perform a pregnancy test.

         10. Impaired cognition