Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine | Experimental | Experimental group will receive ISNB with admixed LB (10 mL) and 0.5% bupivacaine (10 mL) total of 20 mL. |
|
| Non-liposomal Bupivacaine | Active Comparator | Comparator group will receive ISNB with 20 mL of 0.5% non-liposomal bupivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | Validate the analgesic efficacy of admixed LB + bupivacaine compared with plain bupivacaine when injected for ISNB for total shoulder arthroplasty. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | Morphine equivalents used during first 72 hours after surgery | 72 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale Reported Pain Scores | Patient reported pain scores using the numeric rating scale from 0 to 10 where 0 means no pain and 10 means worst possible pain | 72 hours postoperative |
| Nerve Block Related Adverse Events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Donald A Elmer, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Medical Center | Charlottesville | Virginia | 22903 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Bupivacaine | Drug | Active comparator as standard of care. |
|
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.
| 72 hours postoperative |
| Patients with Additional, Unanticipated Pain Related Medical Encounters | 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 | 72 hours postoperative |
| Patient Reported Satisfaction with Postoperative Pain Control Using the Numeric Rating Scale | 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 | 72 hours postoperative |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |