Phase 4 N=57 Randomized Single-blind Treatment

Liposomal Bupivacaine in Total Shoulder Arthroplasty

Pain

Bottom Line

View on ClinicalTrials.gov: NCT02570022 ↗

Enrolled (actual)

Serious AEs

1.8%

Results posted

Oct 2016

Primary outcome: Primary: Pain Levels — 4.8; 4.0; 4.7; 4.0 units on a scale — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Liposomal bupivacaine (Drug); Inter-scalene nerve block (Procedure); Ropivacaine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Henry Ford Health System
Primary completion: May 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Levels	4.8; 4.0; 4.7; 4.0; 4.3; 3.6	<0.05 sig
SECONDARY Morphine Equivalents	14.8; 21.4; 8.9; 9.1; 12.3; 5.2	—

Summary

This is a randomized, single blinded, standard of care controlled clinical trial. All adult patients over eighteen desiring shoulder arthroplasty will be eligible. The study compares pain control and opioid consumption in patients undergoing shoulder arthroplasty between patients receiving liposomal bupivacaine and those who underwent a preoperative inter-scalene nerve block.

Eligibility Criteria

Inclusion Criteria

Patients over the age of 18 scheduled for primary shoulder arthroplasty by three fellowship trained surgeons will be eligible for inclusion

Exclusion Criteria

Patients will be excluded if their medical history presents known allergies or intolerance to dexamethasone, opioid or bupivacaine, substantial alcohol or drug abuse, and pregnancy.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02570022). 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.