Liposomal Bupivacaine for Pain Control After Total Shoulder Arthroplasty
Condition: Osteoarthritis; Arthropathy; Shoulder Pain; Closed Fracture Proximal Humerus, Four Part
MeSH terms: Shoulder Pain; Fractures, Closed
Study type: Interventional

Summary: 
      This study will compare interscalene nerve block versus liposomal bupivacaine (Exparel) for
      pain control after total shoulder replacements. Each method will be assessed in terms of post
      operative pain scores, pain medication consumption, length of stay, complications (nerve
      injuries, hematomas, cardiac/respiratory events) and rate of readmission due to pain. The
      aims of this study will be achieved through a randomized controlled trial and
      cost-effectiveness analysis.
    

Detailed description: 
      After the decision to proceed with shoulder replacement surgery, patients will be asked to
      participate in this randomized trial. Consent will be completed after explanation of each
      treatment group and the data to be collected. Patients will be randomized into one of the two
      treatment groups by simple randomization into one of two groups: Group 1 will receive
      interscalene nerve block and group 2 will receive liposomal bupivacaine for postoperative
      analgesia. Randomization will be stratified by site.

      The surgeon at each site will be trained prior to enrollment on the correct way to perform
      Exparel injections intraoperatively. Patients in the interscalene nerve block group will be
      given a single shot block in the preoperative area by a fellowship-trained anesthesiologist.

      The primary outcome is pain score on a visual analog scale (VAS) at 24 hours postoperatively.
      VAS pain scores range from 0 (no pain) to 10 (unbearable pain). Secondary outcomes are
      postoperative VAS pain scores at 6, 12, 18, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and
      96 hours; VAS pain score at the first postoperative visit ; intraoperative opioid
      consumption; postoperative opioid consumption at days 1, 2, 3, and 4; total opioid
      consumption at day 1 (intraoperative + postoperative day 1); duration of stay in the
      post-anesthesia care unit (PACU); duration of hospital stay; and VAS score for satisfaction
      with pain control in the hospital and at home, assessed at participants' first postoperative
      visit. VAS satisfaction scores range from 0 (not satisfied) to 10 (completely satisfied).
    

Intervention name(s): Liposomal bupivacaine; Interscalene Nerve Block
Intervention type(s): Drug; Drug
Intervention description(s): Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.; Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.
Other intervention name(s): Exparel
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment