Phase 4
N=111
Pec Infiltration With Liposomal Bupivacaine for Breast Surgery
Acute Pain
Bottom Line
View on ClinicalTrials.gov: NCT03599635 ↗Enrolled (actual)
111
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Total Opioid Use — 0.0; 0.0 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- liposomal bupivacaine (Drug); Bupivacaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Minnesota
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Opioid Use |
0.0; 0.0 | — |
| SECONDARY Maximal Pain Scores - 1 Hour |
1.0; 2.0 | — |
| SECONDARY Maximal Pain Scores - 2 Hours |
1.5; 1.0 | — |
| SECONDARY Maximal Pain Scores - 6 Hours |
1.0; 2.0 | — |
| SECONDARY Maximal Pain Scores - 24 Hours |
1.0; 2.0 | — |
| SECONDARY Maximal Pain Scores - 48 Hours |
1.0; 2.0 | — |
| SECONDARY Maximal Pain Scores - 72 Hours |
1.0; 1.0 | — |
| SECONDARY Improved Quality of Recovery Score |
142.0; 138.0 | — |
| SECONDARY Effect in Patients With Breast Surgery |
2.0; 4.0 | — |
Summary
The purpose of this study is to compare pain control after breast surgery using either liposomal bupivacaine or bupivacaine when infiltrated during an ultrasound guided pectoralis 1 and 2 block. Both medications, liposomal bupivacaine and bupivacaine, are standard of care in these types of surgeries.
Eligibility Criteria
Inclusion Criteria
- • All patients undergoing partial mastectomy procedures.
- Ages 18-75
Exclusion Criteria
- • Patient on chronic anticoagulation
- Pregnant women
- Non-english speaking patients
- Any individuals who are unable to give informed consent
- Any individual with diminished capacity to give informed consent
- Allergy to local anesthetics
- Patients who remain intubated overnight after surgery or who are unable to provide information regarding their pain immediately postoperatively
- Daily use of opioid for more than three weeks
- Significant liver disease, defined as liver enzymes greater than 3x the upper limit of normal
- Lack of patient cooperation including those patients who refuse a MAC anesthetic
- Contraindication to regional anesthesia
- Infection at injection site
- Inability to guarantee sterile equipment or sterile conditions for the block
- Patient refusal
- Severe Coagulopathy or bleeding disorder
Data sourced from ClinicalTrials.gov (NCT03599635). 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.