Pain Management, Total Shoulder Arthroplasty
Conditions
Keywords
ZYNRELEF, Total shoulder arthroplasty
Brief summary
The purpose of this study is to determine if local intra-operative application of ZYNRELEF (topical medication) during shoulder replacement surgery improves pain control (as defined by opioid consumption after surgery) compared to the use of an interscalene block with catheter. This is a randomized clinical trial without blinding. Subjects will complete patient reported outcomes before and after surgery. Subjects will track their narcotic use, pain scores and pain satisfaction after surgery.
Interventions
DRUGZynrelef
ZYNRELEF
DRUGBupivacaine
Interscalene block with continuous catheter pump
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients 18 years or older 2. Indicated to undergo primary total shoulder arthroplasty (anatomic or reverse)
Exclusion criteria
1. Any persons unable to consent, will not be eligible 2. Patients undergoing revision arthroplasty or reverse shoulder arthroplasty 3. Proximal humerus fractures 4. Inability to have interscalene anesthetic catheter placement 5. Compromised baseline renal function (CrCl \< 50) 6. BMI \> 40 7. History of GI bleed, prior duodenal surgery, or gastric sleeve resection 8. Current narcotic use or prior consistent narcotic exposure in the last 6 months 9. Use of perioperative oral steroid medications 10. Active Workman's compensation claim 11. Prior shoulder arthroplasty on the contralateral side in which an interscalene catheter was used
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Narcotic consumption | From surgery to two-weeks following surgery | Narcotic consumption measured in morphine equivalent units (MEU) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain management cost | Perioperative | Total cost of the interscalene single shot block plus Zynrelef compared to the cost of the block plus catheter with pain pump |
| Pain management administration | Perioperative | Time needed by the anesthesiologists to perform the blocks in both groups. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlexander Aleem, MD
Washington University School of Medicine
Outcome results
None listed