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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 19 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

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

More Details

Status
Completed
Sponsor
University of Alabama at Birmingham

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.