liposomal bupivacaine for Acute Pain

M Health Ambulatory Surgery Center, Minneapolis, MN
Acute Painliposomal bupivacaine - Drug
18 - 75

Study Summary

This trial is looking at which of two standard pain control methods is better for breast surgery patients.

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: time from end of surgery through 72 hours after surgery

Hour 72
Maximal pain scores
Total opioid use

Trial Safety

Phase-Based Safety

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

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2 Treatment Groups

1 of 2
liposomal bupivacaine
1 of 2

Active Control

Experimental Treatment

112 Total Participants · 2 Treatment Groups

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

liposomal bupivacaine
Experimental Group · 1 Intervention: liposomal bupivacaine · Intervention Types: Drug
ActiveComparator Group · 1 Intervention: Bupivacaine · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: time from end of surgery through 72 hours after surgery

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,299 Previous Clinical Trials
1,496,278 Total Patients Enrolled
11 Trials studying Acute Pain
1,625 Patients Enrolled for Acute Pain
Jason Habeck, MDPrincipal InvestigatorUniversity of Minnesota

Eligibility Criteria

Age 18 - 75 · Female Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are having a type of breast surgery called partial mastectomy.