Phase 4
N=104
Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty
Arthropathy Shoulder
Bottom Line
View on ClinicalTrials.gov: NCT03663283 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Patient Pain Scores — 4.0; 2.8 score on a scale — p=.0197
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Liposomal Bupivacaine (Drug); Bupivacaine Hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Pain Scores |
4.0; 2.8 | .0197 sig |
| SECONDARY Opioid Consumption |
45.6; 56.2; 133.9; 150.9 | 0.584 |
| SECONDARY Time to Cessation of Nerve Blockade |
16; 12; 31; 19; 38; 28 | 0.11 |
| SECONDARY Satisfaction With Pain Control Using Satisfaction Scale |
6.6; 6.9; 7.5; 7.8 | .7018 |
Summary
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.
Eligibility Criteria
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 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)
Data sourced from ClinicalTrials.gov (NCT03663283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.