Liposomal bupivacaine for Total Shoulder Replacement

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Total Shoulder ReplacementLiposomal bupivacaine - Drug
Eligibility
50 - 85
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether adding a certain medication to a common pain-relieving treatment for shoulder surgery results in less pain, fewer narcotics needed, and higher satisfaction for patients.

Eligible Conditions
  • Total Shoulder Replacement

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively

Postoperatively (at 1 week)
Severity of pain and its impact on functioning (Brief Pain Inventory - Short Form modified)
Postoperatively (at 4 weeks)
Satisfaction with the results of surgery (Self-Administered Patient Satisfaction Scale)
Week 1
Narcotic usage
Non narcotic pain medication usage
Week 4
American Shoulder and Elbow Surgeons (ASES) score: preoperatively, postoperatively, and change from preoperatively to postoperatively
Pain score (Numeric Rating Scale): Preoperatively, postoperatively, and change from preoperatively to postoperatively

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Control group
1 of 2
Study group
1 of 2

Active Control

Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: Liposomal bupivacaine · No Placebo Group · Phase 4

Study groupExperimental Group · 2 Interventions: Liposomal bupivacaine, Bupivacaine · Intervention Types: Drug, Drug
Control group
Drug
ActiveComparator Group · 1 Intervention: Bupivacaine · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved
Bupivacaine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively

Who is running the clinical trial?

Scripps ClinicLead Sponsor
12 Previous Clinical Trials
28,263 Total Patients Enrolled
Heinz Hoenecke, MDPrincipal InvestigatorScripps Health

Eligibility Criteria

Age 50 - 85 · All Participants · 1 Total Inclusion Criteria

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