Phase 4
Completed N=70
Exparel for Postoperative Pain Management in Shoulder Surgery
Fracture of Shoulder and Upper Arm
Source: ClinicalTrials.gov NCT02472314 ↗
Enrolled (actual)
70
Serious AEs
1.4%
Results posted
Apr 2019
Primary outcomePrimary: Quality of Analgesia — 2.1; 2.6; 4.1; 4.0 score on a scale
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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
The purpose of this study is to compare the effect of liposomal Bupivacaine infiltration into the shoulder to continues nerve block with Bupivacaine on postoperative pain control and functional outcomes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Analgesia |
2.1; 2.6; 4.1; 4.0; 3.4; 2.6 | — |
| SECONDARY Post Operative American Shoulder and Elbow Surgeons (ASES) |
36.1; 27.7; 59.5; 57.3; 74.5; 59.7 | — |
| SECONDARY Subjective Shoulder Value (SSV) |
30.7; 24.3; 55.7; 63.1; 70.0; 69.3 | — |
| SECONDARY Incidence of Nerve Injury |
0; 0 | — |
| SECONDARY Post Operative Opioid Consumption |
78.6; 52.8 | — |
Eligibility Criteria
Inclusion Criteria
- Patients undergoing shoulder arthroplasty under general anesthesia
- Patients undergoing open reduction internal fixation (ORIF) of a proximal humerus fracture under general anesthesia
- Patients with American Society of Anesthesiologist (ASA) physical status classification of 1-3
- Patients meeting criteria for standard of care continuous peripheral nerve block (CPNB) per anesthesia guidelines.
- Patients agreeing to be available for brief follow up telephone survey post- operatively and being mentally able to respond.
- Patients available for follow up routine post-operative clinic visits, per standard of care.
Exclusion Criteria
- Contraindications to regional anesthesia
- Significant peripheral neuropathy or neurological disorder affecting the upper extremity
- Contraindication to a component of multimodal analgesia
- Pregnancy
- Opioid tolerance
- Cognitive or psychiatric condition that might affect patient assessment and/or inability to provide informed consent.
Data sourced from ClinicalTrials.gov (NCT02472314). 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.