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.
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
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 group | Role | What they receive |
|---|---|---|
| liposomal bupivacaine | Experimental | These patients will receive liposomal bupivacaine for a pectoralis block infiltration by the anesthesiologist. Receives: Drug: liposomal bupivacaine |
| bupivacaine | Active comparator | These 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.
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)
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
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
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
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
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
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
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
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.
- First posted26 Jul 2018
- Study start1 Jul 2018
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Habeck, MD, Principal investigator, University of Minnesota
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Pec Infiltration With Liposomal Bupivacaine for Breast Surgery: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03599635
- Acronym / sponsor ID
- ANES-2017-25584
- Conditions
- Acute Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 11 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liposomal bupivacaine | Experimental | Drug: liposomal bupivacaineThese patients will receive liposomal bupivacaine for a pectoralis block infiltration by the anesthesiologist. |
| bupivacaine | Active comparator | Drug: BupivacaineThese patients will receive incisional bupivacaine infiltration by the surgeon. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • All patients undergoing partial mastectomy procedures.
Key exclusion criteria (15 listed)
- • Patient on chronic anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liposomal bupivacaineExperimental | Drug | liposomal bupivacaine |
| BupivacaineActive Comparator | Drug | bupivacaine |
Primary outcome
Total Opioid Use
Time frame: time from end of surgery through 72 hours after surgery
Description: To determine if liposomal bupivacaine Pec infiltration provides decreased peri-operative opioid usage when compared to incisional bupivacaine infiltration.
8 secondary outcomes
Maximal Pain Scores - 1 Hour
Time frame: 1 hour
Maximal Pain Scores - 2 Hours
Time frame: 2 hours
Maximal Pain Scores - 6 Hours
Time frame: 6 hours
Maximal Pain Scores - 24 Hours
Time frame: 24 hours
Maximal Pain Scores - 48 Hours
Time frame: 48 hours
Maximal Pain Scores - 72 Hours
Time frame: 72 hours
Improved Quality of Recovery Score
Time frame: 1 year
Effect in Patients With Breast Surgery
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Habeck, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
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.