Exparel for Total Shoulder Arthroplasty
Condition: Total Shoulder Arthroplasty
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to determine if Exparel leads to better pain scores at
      24, 48 and 73 hours after Total Shoulder Arthroplasty (TSA) compared to a pain pump.
      Secondary objectives are (1) to determine if patients on Exparel use less narcotics and (2)
      have earlier return of functional use of the involved arm after surgery compared to the pain
      pump and (3) if use of Exparel leads to cost savings

      METHODS

      Sample size:

      Based on prior studies on anesthetics for TSA, the mean worst pain score in the 24 hours
      after surgery was 5.4, based on a 0 to 10 scale. To detect a change of 2 points, alpha of
      0.05, beta of 0.80, a sample size of 51 subjects in each group will be required. To account
      for drop-outs, a total of 60 subjects in each arm will be enrolled.

      Inclusion criteria Patients undergoing unilateral primary TSA or reverse TSA Indication for
      surgery is osteoarthritis, rotator cuff arthropathy or massive irreparable rotator cuff tears
      Surgery performed by the Principal Investigator Anesthesia administered by Co-Principal
      Investigator Willing and able to sign an Informed Consent Exclusion criteria Indication for
      surgery is fracture Comorbid psychiatric diagnosis requiring therapy and/or medication except
      anxiety or depression Comorbid chronic pain syndrome (reflex sympathetic dystrophy,
      fibromyalgia) Has hepatic disease On workers compensation/disability/litigation Known adverse
      reaction to medications to be administered On long-acting narcotic pain medication (including
      extended release narcotic pain medications and methadone) Home Oxygen requirement whether as
      needed or scheduled. Contralateral Phrenic Nerve paralysis / incompetence. Body Mass Index ≥
      50 Randomization will be a varied blocked randomization with blocks of 12, 15 and 18 using
      sealed envelopes

      Treatment arms:

      Control: Pain catheter based pain control. Subject will receive an interscalene block with
      Ropivicaine 0.5% (20cc), and then a pain pump attached in the Post Anesthesia Care Unit
      infusing at 4cc/hr. The patient will go home with that device until it runs out.

      Interventional: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine

      Both arms will receive the same multimodal analgesia medications preoperatively. Celebrex
      400mg PO, Gabapentin 600mg PO, Tylenol 1 gram PO, unless contraindicated.
    

Detailed description: 
      The primary objective of this study is to determine if Exparel leads to better pain scores at
      24, 48 and 73 hours after TSA compared to a pain pump. Secondary objectives are (1) to
      determine if patients on Exparel use less narcotics and (2) have earlier return of functional
      use of the involved arm after surgery compared to the pain pump and (3) if use of Exparel
      leads to cost savings

      METHODS

      Sample size:

      Based on prior studies on anesthetics for TSA, the mean worst pain score in the 24 hours
      after surgery was 5.4, based on a 0 to 10 scale. To detect a change of 2 points, alpha of
      0.05, beta of 0.80, a sample size of 51 subjects in each group will be required. To account
      for drop-outs, a total of 60 subjects in each arm will be enrolled.

      Inclusion criteria Patients undergoing unilateral primary TSA or reverse TSA Indication for
      surgery is osteoarthritis, rotator cuff arthropathy or massive irreparable rotator cuff tears
      Surgery performed by the Principal Investigator Anesthesia administered by Co-Principal
      Investigator Willing and able to sign an Informed Consent Exclusion criteria Indication for
      surgery is fracture Comorbid psychiatric diagnosis requiring therapy and/or medication except
      anxiety or depression Comorbid chronic pain syndrome (reflex sympathetic dystrophy,
      fibromyalgia) Has hepatic disease On workers compensation/disability/litigation Known adverse
      reaction to medications to be administered On long-acting narcotic pain medication (including
      extended release narcotic pain medications and methadone) Home Oxygen requirement whether as
      needed or scheduled. Contralateral Phrenic Nerve paralysis / incompetence. Body Mass Index ≥
      50 Randomization will be a varied blocked randomization with blocks of 12, 15 and 18 using
      sealed envelopes

      Treatment arms:

      Control: Pain catheter based pain control. Subject will receive an interscalene block with
      Ropivicaine 0.5% (20cc), and then a pain pump attached in the Post Anesthesia Care Unit
      infusing at 4cc/hr. The patient will go home with that device until it runs out.

      Interventional: Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine

      Both arms will receive the same multimodal analgesia medications preoperatively. Celebrex
      400mg PO, Gabapentin 600mg PO, Tylenol 1 gram PO, unless contraindicated.
    

Intervention name(s): Exparel; Pain Pump
Intervention type(s): Drug; Drug
Intervention description(s): Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine; Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Total Shoulder Arthroplasty; Post-operative Pain; Pain pump; Liposomal Bupivacaine