This trial is looking at which of two standard pain control methods is better for breast surgery patients.
This is further along than 93% of similar trials
1 Primary · 1 Secondary · Reporting Duration: time from end of surgery through 72 hours after surgery
Maximal pain scores
Total opioid use
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.
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.
2 Treatment Groups
1 of 2
1 of 2
112 Total Participants · 2 Treatment Groups
Primary Treatment: liposomal bupivacaine · No Placebo Group · Phase 4
DrugExperimental Group · 1 Intervention: liposomal bupivacaine · Intervention Types: Drug
DrugActiveComparator Group · 1 Intervention: Bupivacaine · Intervention Types: Drug
Drug Approval Stage
How many patients have taken this drug
Screening: ~3 weeks
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
Age 18 - 75 · Female Participants · 1 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
You are having a type of breast surgery called partial mastectomy.