Pec Infiltration With Liposomal Bupivacaine for Breast Surgery

NCT03599635 | Completed Phase 4 Results FDA Drug

• 1 other identifier: ANES-2017-25584
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• Total Opioid Use

  Description: To determine if liposomal bupivacaine Pec infiltration provides decreased peri-operative opioid usage when compared to incisional bupivacaine infiltration.

  time from end of surgery through 72 hours after surgery

Secondary Outcomes (8)

• Maximal Pain Scores - 1 Hour

  1 hour

• Maximal Pain Scores - 2 Hours

  2 hours

• Maximal Pain Scores - 6 Hours

  6 hours

• Maximal Pain Scores - 24 Hours

  24 hours

• Maximal Pain Scores - 48 Hours

  48 hours

Study Arms (2)

liposomal bupivacaine

EXPERIMENTAL

These patients will receive liposomal bupivacaine for a pectoralis block infiltration by the anesthesiologist.

Drug: liposomal bupivacaine

bupivacaine

ACTIVE COMPARATOR

These patients will receive incisional bupivacaine infiltration by the surgeon.

Drug: Bupivacaine

Interventions

liposomal bupivacaine DRUG

Experimental

liposomal bupivacaine

Bupivacaine DRUG

Active Comparator

bupivacaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing partial mastectomy procedures.
• Ages 18-75

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

M Health Ambulatory Surgery Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Jason Habeck
• Organization: University of Minnesota

habe0073@umn.edu

612-624-9990

Study Officials

• Jason Habeck, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: July 26, 2018
• Study Start: July 1, 2018
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: December 11, 2025
• Results First Posted: December 11, 2025

Record last verified: 2025-12

Locations

US (1)