Liposomal Bupivacaine in Rotator Cuff Repair
- Registration Number
- NCT03738696
- Lead Sponsor
- University of Alabama at Birmingham
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Liposomal bupivacaine Interscalene Block Exparel Interscalene block: * 10cc (133mg) liposomal bupivacaine;PLUS * 10cc 0.25% bupivacaine Ropivacaine Interscalene Catheter Ropivacaine * 20cc 0.25% bupivacaine interscalene block; PLUS * Ropivacaine 0.25% interscalene catheter (6ml/hr for 48hrs)
- Primary Outcome Measures
Name Time Method Average Postoperative Pain Scores Over a 96 Hour Timeframe Up to 96 hrs postoperative Visual analog pain scores after operation \[0-10, with 10 being the worst pain\]
- Secondary Outcome Measures
Name Time Method Average Hours of Painless Sleep Up to 96 hrs postoperative Hours of sleep uninterrupted by pain \[numerical, hours\]
Average Postoperative Oral Morphine Equivalents Over a 96 Hour Timeframe Up to 96 hrs oral morphine equivalents of all opioid-containing medications received
Average Sleep Quality Over a 96 Hour Timeframe Up to 96 hrs postoperative Scale of sleep quality \[0-10, with 10 being the most satisfied\]
Percentage of Participants With Analgesia Complications Up to 96 hrs Complications resulting from the method of analgesia utilized
Average Analgesia Satisfaction Over a 96 Hour Timeframe Up to 96 hrs Likert scale of analgesia satisfaction \[0-5, with 5 being the most satisfied\]
Trial Locations
- Locations (1)
UAB Hospital-Highlands
🇺🇸Birmingham, Alabama, United States