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Acute PainPhase 4NCT03599635

Pec Infiltration With Liposomal Bupivacaine for Breast Surgery

A Phase 4 study testing liposomal bupivacaine and Bupivacaine in people with Acute Pain, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Acute Pain
What is being tested?
liposomal bupivacaine and Bupivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteUnited States
Study dates
1 Jul 2018to 1 Jul 2024
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • M Health Ambulatory Surgery Center

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: Ultrasound-guided Pec Infiltration With Liposomal Bupivacaine for Breast Surgery: A Prospective Randomized Study

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.

Read the detailed description

For the Pec infiltration, the patient will be in the supine position. The pectoralis major and pectoralis minor muscle layers will be identified via ultrasound. Using sterile technique, a nerve block needle will be inserted and advanced under ultrasound guidance until it is below the fascial covering of the pec minor muscle layer. Gentle aspiration for air or blood will be performed in 5cc incremental doses. Then injection of 10 mL of bupivacaine 0.25% with epinephrine 1:200,000 and 10mL of a mixture of liposomal bupivacaine and saline (5 mL liposomal bupivacaine and 5 mL saline) for a total injection for pec 1 block of 20 mL. For each 5cc of local anesthetic injected, aspiration will be performed. Upon completion of the injection the needle will be removed. The investigators will then use the ultrasound probe to identify the second rib on anterolateral chest wall and move the probe to the 4th rib. Here the investigators will identify the pec minor and serratus anterior muscles. They will advance their needle under ultrasound-guidance beneath pec minor and above serratus anterior. Here an injection 10 mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 20 mL mixture of 15 mL liposomal bupivacaine and 5 mL saline for a total volume of 30ml for Pec 2. block will occur.

Upon completion of the injection, the needle will then be removed and the patient will be monitored in the preoperative area until he/she is brought into the operating room for their procedure.

If deemed necessary for coverage the surgeon will be allowed to inject additional local anesthetic up to a maximum of 40 mL of 0.25% bupivacaine. This will be noted in the chart.

For the surgeon infiltration, the patient will be brought directly to the operating room where intraoperative anesthetic with an opioid-sparing MAC technique will be provided as described below. Just prior to the skin incision, 0.25% bupivacaine will be used to infiltrate the dermis and subcutaneous space in the proposed incision. Throughout the procedure, additional incisional bupivacaine infiltration into the surrounding tissues will be performed as needed for local anesthesia. A total of up to 30 mL of 0.25% bupivacaine will be divided equally for the two sides of the incision. An additional 5 mL of 0.25% bupivacaine will be infiltrated into the pectoralis major muscle at the deep margin of resection. Accidental intravascular injection is minimized by continuous needle movement and frequent aspiration.

The following vital signs will be monitored throughout the procedure: Heart rate, blood pressure, oxygen saturation, and respirations, and patient's state of consciousness. The investigators will monitor the patient until they are brought to the operating room for surgery.

All patients will receive multimodal analgesia in the preoperative area. They will receive 975 mg of oral acetaminophen and 300 mg of gabapentin orally prior to surgery. 30 mg of ketorolac will be given just prior to closure in the operating room.

The intraoperative anesthetic will be an opioid-sparing MAC anesthetic. Patients will receive IV midazolam 0-2 mg followed by 40-100mg of IV lidocaine, and followed by a propofol infusion with 2 mg/ml of ketamine. Opioids will be avoided unless HR or BP increases by 20 % above baseline. Then only short acting opioids (fentanyl) will be given. If patients are unable to tolerate procedure under MAC they would be converted to a general anesthetic with an laryngeal mask airway (LMA).

In the recovery room if the patient experiences pain greater than 5/10 they will receive either IV or oral pain medications. If pain score is less than 5 patients will get non opioid medications unless the patient desires an opioid medication.

When the operation is complete the patient will either be brought to the PACU or Phase II. Each day a member of the research team will call and evaluate the patient for signs of complications and ask the patient their minimum and maximum pain score (scores will be evaluated at 1 hr, 2 hr, 6hrs, 24hrs, 48hrs, 72hrs). They will record daily opioid use, any modality related complications, how many phone calls were made regarding pain control and modality related complications. At time period 72 hours a Quality of recovery survey (see appendix) and OBAS (see appendix) survey will be presented to patient.

At 3 months, 6 months, and 12 months patients will be called to answer a survey with regards to chronic pain.

Patients will be instructed to take acetaminophen 1000 mg every 8 hours while at home and alternate that every four hours with ibuprofen 800 mg every 8 hours. They will be given a prescription of opioid pain medications either oxycodone or hydrocodone and will be instructed to take as needed for pain.

Conditions
Acute Pain
Being tested
liposomal bupivacaine, Bupivacaine
Medical subject headings
Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • liposomal bupivacaineDrug

    Experimental

  • BupivacaineDrug

    Active Comparator

Study groups in NCT03599635
Study groupRoleWhat they receive
liposomal bupivacaineExperimentalThese patients will receive liposomal bupivacaine for a pectoralis block infiltration by the anesthesiologist.
Receives: Drug: liposomal bupivacaine
bupivacaineActive comparatorThese patients will receive incisional bupivacaine infiltration by the surgeon.
Receives: Drug: Bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Opioid Use

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

    Measured: time from end of surgery through 72 hours after surgery

Secondary outcomes (8)
  1. Maximal Pain Scores - 1 Hour

    total additive maximal patient pain scores measured using a numerical rating scale pain score 0-10 at time points 1 hour, 2, hours, 6 hours, 24 hours, 48 hours, and 72 hours. Higher pain score is worse pain score.

    Measured: 1 hour

  2. Maximal Pain Scores - 2 Hours

    total additive maximal patient pain scores measured using a numerical rating scale pain score 0-10 at time points 1 hour, 2, hours, 6 hours, 24 hours, 48 hours, and 72 hours. Higher pain score is worse pain score.

    Measured: 2 hours

  3. Maximal Pain Scores - 6 Hours

    total additive maximal patient pain scores measured using a numerical rating scale pain score 0-10 at time points 1 hour, 2, hours, 6 hours, 24 hours, 48 hours, and 72 hours. Higher pain score is worse pain score.

    Measured: 6 hours

  4. Maximal Pain Scores - 24 Hours

    total additive maximal patient pain scores measured using a numerical rating scale pain score 0-10 at time points 1 hour, 2, hours, 6 hours, 24 hours, 48 hours, and 72 hours. Higher pain score is worse pain score.

    Measured: 24 hours

  5. Maximal Pain Scores - 48 Hours

    total additive maximal patient pain scores measured using a numerical rating scale pain score 0-10 at time points 1 hour, 2, hours, 6 hours, 24 hours, 48 hours, and 72 hours. Higher pain score is worse pain score.

    Measured: 48 hours

  6. Maximal Pain Scores - 72 Hours

    total additive maximal patient pain scores measured using a numerical rating scale pain score 0-10 at time points 1 hour, 2, hours, 6 hours, 24 hours, 48 hours, and 72 hours. Higher pain score is worse pain score.

    Measured: 72 hours

  7. Improved Quality of Recovery Score

    To determine if a pectoralis 1 and 2 block with liposomal bupivacaine improves quality of recovery score post-operatively when compared to incisional bupivacaine infiltration. The scale used was QR15 with 0 to 150 scale; 0 is non of the time/poor, 150 all of the time/excellent.

    Measured: 1 year

  8. Effect in Patients With Breast Surgery

    To observe the effect on chronic postoperative pain in patients who have breast surgery, measured with the Overall Benefit of Analgesia Score (OBAS), where 0 is minimal pain and 4 is maximum pain.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2018
  2. Study start1 Jul 2018
  3. Primary completion1 Jul 2024
  4. Study completion1 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03599635
Sponsor's protocol ID
ANES-2017-25584
Status last verified
Dec 2025
First submitted
20 Jun 2018
Last updated
11 Dec 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing liposomal bupivacaine and Bupivacaine in people with Acute Pain, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Opioid Use (time frame: time from end of surgery through 72 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.

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