Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty
Completed · Phase 4
Conditions studied: Arthropathy Shoulder
In brief
The objective of this study is to determine if peripheral nerve block with liposomal bupivacaine in combination with standard bupivacaine will prolong the duration of block, improve pain scores, and decrease opioid utilization in the post-operative period when compared to peripheral nerve block with standard bupivacaine alone.
Key facts
- Study ID
- NCT03663283
- Run by
- Mayo Clinic
- People needed
- 104
- Starts
- 2018-10-29
- Expected to finish
- 2020-02-14
- Last updated by the study team
- 2021-02-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All adult patients (>18 years of age)
- Patients undergoing standard or reverse total shoulder arthroplasty for the primary diagnoses of glenohumeral arthritis or cuff tear arthropathy
- Cognitively intact with the ability to give informed consent as outlined by our institutional review board.
- Patients must be capable of participating in the post-operative electronic survey and / or able to maintain a written diary of events
You may not qualify if…
- Non-elective cases
- Infection, tumor, trauma
- Weight < 50 kg
- Patients with any contraindications to regional anesthesia including allergy or hypersensitivity to amide-type local anesthetics
- Patients with allergy to any component of medication regimen e.g. amide- type local anesthetics, oxycodone, hydromorphone, fentanyl
- Chronic pain patients with history of chronic opioid use (defined as 20 mg morphine equivalent / day for greater than 30 days pre-operatively
- Concurrent painful physical condition that may require analgesic treatment that is not related to the shoulder surgery (chronic peripheral neuropathy, radiculopathy, or other neurologic disorder)
- Severe hepatic disease defined by clinical evidence of liver disease with abnormal liver function tests.
- Pregnancy
- Respiratory disease that contraindicates interscalene nerve block (elevated contralateral hemidiaphragm, contralateral pneumonectomy, or severe COPD with FEV1 < 50% predicted, and 02 dependence)
Where it is running
- Mayo Clinic in Arizona — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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