Phase 4
Completed N=86
Opioid-Free Shoulder Arthroplasty
Source: ClinicalTrials.gov NCT03540030 ↗Enrolled (actual)
86
Serious AEs
3.5%
Results posted
Oct 2020
Primary outcomePrimary: Post Op Pain — 3.0; 2.0 score on a scale — p=.297
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Purpose of Study:
To identify and provide a safe, opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post Op Pain |
3.0; 2.0 | .297 |
| SECONDARY Additional Post Op Pain |
2; 0.0; 4; 0; 1.3; 0.82 | 0.005 sig |
| SECONDARY Nausea |
0; 1; 28; 30; 2; 0 | >.99 |
| SECONDARY Constipation |
7; 4; 21; 27; 2; 4 | 0.3177 |
| SECONDARY Falls |
4; 4; 24; 27; 2; 4 | >.99 |
| SECONDARY Morphine Use |
45.0; 19.0 | — |
| SECONDARY Pain Satisfaction |
23; 29; 5; 2; 2; 4 | 0.2349 |
| SECONDARY ASES |
54.3; 54.2 | 0.9669 |
| SECONDARY Simple Shoulder Test |
6; 6 | 0.7892 |
| SECONDARY Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore |
38.4; 40.3; 58.7; 60.8 | 0.2023 |
Eligibility Criteria
Inclusion Criteria
- Patient undergoing elective primary total shoulder or reverse total shoulder arthroplasty for osteoarthritis, avascular necrosis, cuff tear arthropathy, or inflammatory arthritis etiologies
- Age greater than or equal to 50.
Exclusion Criteria
- Revision total shoulder arthroplasty
- Chronic opioid therapy - per investigator discretion
- Liver or renal insufficiency - per investigator discretion
- Arthroplasty for fracture
- Sickle cell disease
- Workers compensation
- Inability to receive block
- Intervention Arm Only: Creatinine clearance less than 30 mL/min
- Intervention Arm Only: Allergy to non-steroidal anti-inflammatory medications (NSAIDs).
Data sourced from ClinicalTrials.gov (NCT03540030). 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. Informational only — not medical advice.