N/A
Completed N=108
Liposomal Bupivacaine for Pain Control After Total Shoulder Arthroplasty
Osteoarthritis · Arthropathy · Postoperative Pain · Closed Fracture Proximal Humerus, Four Part
Source: ClinicalTrials.gov NCT02762071 ↗
Enrolled (actual)
108
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Visual Analog Scale Pain Score at 24 Hours Postoperatively — 5.0; 4.9 score on a scale
Summary
This study will compare interscalene nerve block versus liposomal bupivacaine (Exparel) for pain control after total shoulder replacements. Each method will be assessed in terms of post operative pain scores, pain medication consumption, length of stay, complications (nerve injuries, hematomas, cardiac/respiratory events) and rate of readmission due to pain. The aims of this study will be achieved through a randomized controlled trial and cost-effectiveness analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale Pain Score at 24 Hours Postoperatively |
5.0; 4.9 | — |
| SECONDARY Opioid Medication Consumption in Morphine Milligram Equivalents |
38; 60; 21; 25; 18; 36 | — |
| SECONDARY Length of Hospital Stay |
39; 36 | — |
| SECONDARY Postoperative Visual Analog Scale (VAS) Pain Scores |
2.9; 5.1; 4.0; 4.6; 5.2; 4.6 | — |
| SECONDARY Patient Satisfaction With Pain Management |
8.4; 7.8; 8.7; 8.1 | — |
| SECONDARY Length of Stay in the Post-anesthesia Care Unit (PACU) |
102; 139 | — |
Eligibility Criteria
Inclusion Criteria
- Degenerative changes of the shoulder joint (documented by radiographs) in patients planning total joint replacement with one of the study's four fellowship-trained orthopaedic surgeons.
- Patients who require revision surgeries, hemiarthroplasties, or who have chronic pain issues will be included.
Exclusion Criteria
- Allergy to liposomal bupivacaine
- Contraindications to the interscalene nerve block such as:
- Preexisting neurologic defects
- Local anesthetic allergy
- Coagulopathy
- Contralateral phrenic nerve dysfunction
- Severe chronic obstructive pulmonary disease
Data sourced from ClinicalTrials.gov (NCT02762071). 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.