Liposomal Bupivacaine in Rotator Cuff Repair

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy of interscalene liposomal bupivacaine in controlling postoperative pain scores, oral morphine equivalents and sleep quality after arthroscopic rotator cuff repair surgery as compared to interscalene catheter.

Official Title
-----------------
Efficacy of Liposomal Bupivacaine in Arthroscopic Rotator Cuff Repair

Conditions
-----------------
Rotator Cuff Injury

Intervention / Treatment
-----------------
* Drug: Exparel
* Drug: Ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing outpatient arthroscopic rotator cuff repair Greater than or equal to 19 years of age at the time of surgery Exclusion Criteria: Planned operative fixation of the biceps tendon or acromioclavicular joint Opioid use 6 weeks before surgery Gabapentin use 6 weeks before surgery History of prior shoulder surgery on the operative limb Severe pulmonary dysfunction Diagnosis of chronic pain, fibromyalgia or other somatosensory disorder(s) History of radicular pain or neuropathy in the operative limb Patients who are currently incapacitated for medical decision making

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal bupivacaine Interscalene Block<br>Interscalene block: 10cc (133mg) liposomal bupivacaine;PLUS 10cc 0.25% bupivacaine | Drug: Exparel<br>* A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain<br>* Other names: liposomal bupivacaine;|
| Active Comparator: Ropivacaine Interscalene Catheter<br>20cc 0.25% bupivacaine interscalene block; PLUS Ropivacaine 0.25% interscalene catheter (6ml/hr for 48hrs) | Drug: Ropivacaine<br>* A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain scores | Visual analog pain scores after operation [0-10, with 10 being the worst pain] | 0-96 hrs postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative oral morphine equivalents | oral morphine equivalents of all opioid-containing medications received | 0-96 hrs postoperative | 
| Analgesia Satisfaction | Likert scale of analgesia satisfaction [0-5, with 5 being the most satisfied] | 0-96 hrs postoperative | 
| Analgesia Complications | Complications resulting from the method of analgesia utilized | 0-96 hrs postoperative | 
| Sleep quality | Likert scale of sleep quality [0-5, with 5 being the most satisfied] | 0-96 hrs postoperative | 
| Hours of painless sleep | Hours of sleep uninterrupted by pain [numerical, hours] | 0-96 hrs postoperative |