Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 18-005366
NCT ID: NCT03663283
Sponsor Protocol Number: 18-005366
About this study
The purpose 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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 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.
Exclusion Criteria
- 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 elevated liver function tests above normal.
- Pregnancy.
- Respiratory disease that contraindicates interscalene nerve block (elevated contralateral hemidiaphragm, contralateral pneumonectomy, or severe COPD with FEV1 < 50% predicted, and 02 dependence).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Steven Hattrup, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available