Single Shot Liposomal Bupivicaine in Rotator Cuff Surgery
Condition: Rotator Cuff Tear; Pain, Postoperative
MeSH terms: Pain, Postoperative; Rotator Cuff Injuries
Intervention: liposomal bupivicaine; Dexamethasone
Intervention description: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:
Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline; steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine.
Intervention MeSH terms: Dexamethasone; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:
Group 1 (Control) Group 2 Group 3 30 ml of 0.5% bupivacaine and 0.4ml. of dexamethasone 15ml 0.5% bupivacaine and 10ml of LB (Exparel) and 5.4ml normal saline 15ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml dexamethasone and 5ml normal saline
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: This is a double-blinded study, thus, neither the surgeon nor the patient will know which type of interscalene block is used. A total of 78 envelopes containing will be generated consisting of 26 with Group 1", 26 with "Group 2" and 26 with "Group 3" designation. Envelopes will be sealed and randomly chosen by the anesthesiologist prior to surgery. The anesthesiologist will randomly select one of the envelopes which will determine the treatment group and indicate medications that will be included in the interscalene block. Patients will be blinded to the medication utilized as well as the treating surgeon.
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: liposomal bupivicaine; interscalene block

Summary:

      This document is a protocol for a human research study. This study is to be conducted
      according to United States standards of Good Clinical Practice in accordance with applicable
      Federal regulations and institutional research policies and procedures.

      Liposomal bupivacaine (LB) has been shown to decrease post-operative pain and narcotic use
      when administered perioperatively as a local injection during arthroplasty procedures.
      Studies have also demonstrated that LB used in conjunction with dexamethasone may increase
      the duration of effectiveness of LB. This study seeks to evaluate if there is a difference in
      post-operative pain and narcotic use when LB is administered in an interscalene block during
      outpatient rotator cuff repair surgery. Furthermore, this study aims to determine if the
      addition of dexamethasone with LB results in a prolonged decrease in post-operative pain and
      a reduction in narcotic use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 and older

          -  Primary diagnosis of rotator cuff tear

          -  Able to provide informed consent

          -  Is willing and able to accept text messages

        Exclusion Criteria:

          -  Known allergies to the study medications.

          -  Known narcotic or alcohol abuse (< 3 months)

          -  Revision rotator cuff surgery

          -  Contraindication to regional anesthesia

          -  Current narcotic regimen or contract with pain management specialist

          -  Diagnosed with any of the following co-morbidities:

               -  Pre-existing coagulation disorder