Comparison of Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty: a Prospective, Double-blinded, Noninferiority Trial
Overview
- Phase
- Phase 3
- Intervention
- Liposomal bupivacaine
- Conditions
- Analgesia
- Sponsor
- University of Virginia
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Opioid Consumption
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
D. Aric Elmer, MD
Principal Investigator
University of Virginia
Eligibility Criteria
Inclusion Criteria
- •Adults 18 years of age or older
- •Undergoing total shoulder arthroplasty
- •Willing and able to sign consent form to participate in study
Exclusion Criteria
- •\< 18 years of age
- •Unwilling or unable to sign consent form to participate in study
- •Allergy to local anesthetic
- •Medical contraindication to interscalene nerve block
- •Chronic opioid use
Arms & Interventions
Liposomal Bupivacaine
Experimental group will receive ISNB with admixed LB (10 mL) and 0.5% bupivacaine (10 mL) total of 20 mL.
Intervention: Liposomal bupivacaine
Liposomal Bupivacaine
Experimental group will receive ISNB with admixed LB (10 mL) and 0.5% bupivacaine (10 mL) total of 20 mL.
Intervention: Bupivacaine
Non-liposomal Bupivacaine
Comparator group will receive ISNB with 20 mL of 0.5% non-liposomal bupivacaine
Intervention: Bupivacaine
Outcomes
Primary Outcomes
Opioid Consumption
Time Frame: 72 hours postoperative
Morphine equivalents used during first 72 hours after surgery
Secondary Outcomes
- Numeric Rating Scale Reported Pain Scores(72 hours postoperative)
- Nerve Block Related Adverse Events(72 hours postoperative)
- Patient Reported Satisfaction with Postoperative Pain Control Using the Numeric Rating Scale(72 hours postoperative)
- Patients with Additional, Unanticipated Pain Related Medical Encounters(72 hours postoperative)