Analgesia
Conditions
Brief summary
The objective of this study is to validate the analgesic efficacy of admixed Liposomal bupivacaine (LB) + bupivacaine compared with plain bupivacaine when injected for interscalene nerve block (ISNB) for total shoulder arthroplasty (TSA). We hypothesize that admixed LB will be non-inferior to plain bupivacaine in terms of postoperative opioid consumption following TSA. The primary outcome of this study will be opioid consumption over the first 72 hours following surgery. Secondary outcomes will include: pain scores, opioid-related adverse events, block related adverse events, pain related phone calls, pain related ED visits and patient satisfaction.
Interventions
DRUGLiposomal bupivacaine
Validate the analgesic efficacy of admixed LB + bupivacaine compared with plain bupivacaine when injected for ISNB for total shoulder arthroplasty.
DRUGBupivacaine
Active comparator as standard of care.
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults 18 years of age or older * Undergoing total shoulder arthroplasty * Willing and able to sign consent form to participate in study
Exclusion criteria
* \< 18 years of age * Unwilling or unable to sign consent form to participate in study * Allergy to local anesthetic * Medical contraindication to interscalene nerve block * Chronic opioid use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | 72 hours postoperative | Morphine equivalents used during first 72 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale Reported Pain Scores | 72 hours postoperative | Patient reported pain scores using the numeric rating scale from 0 to 10 where 0 means no pain and 10 means worst possible pain |
| Nerve Block Related Adverse Events | 72 hours postoperative | Any adverse event determined to be caused as a result of having a nerve block to include but not limited to toxicity, allergic reaction, nerve injury. |
| Patients with Additional, Unanticipated Pain Related Medical Encounters | 72 hours postoperative | Any unanticipated, unplanned, pain related phone calls to surgeon or anesthesiologist for rescue pain treatment, pain related emergency department visits or primary care physician visits for pain treatment |
| Patient Reported Satisfaction with Postoperative Pain Control Using the Numeric Rating Scale | 72 hours postoperative | Patient reported satisfaction with their postoperative pain control using the numeric rating scale from 0 to 10 where 0 means completely dissatisfied and 10 means completely satisfied |
Countries
United States
Outcome results
None listed