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Pec Infiltration With Liposomal Bupivacaine for Breast Surgery

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03599635
Enrollment
112
Registered
2018-07-26
Start date
2018-07-01
Completion date
2024-07-01
Last updated
2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

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.

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.

Interventions

DRUGliposomal bupivacaine

Experimental

DRUGBupivacaine

Active Comparator

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Total Opioid Usetime from end of surgery through 72 hours after surgeryDescription: To determine if liposomal bupivacaine Pec infiltration provides decreased peri-operative opioid usage when compared to incisional bupivacaine infiltration.

Secondary

MeasureTime frameDescription
Maximal Pain Scores - 2 Hours2 hourstotal 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.
Maximal Pain Scores - 6 Hours6 hourstotal 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.
Maximal Pain Scores - 24 Hours24 hourstotal 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.
Maximal Pain Scores - 1 Hour1 hourtotal 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.
Maximal Pain Scores - 72 Hours72 hourstotal 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.
Improved Quality of Recovery Score1 yearTo 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.
Effect in Patients With Breast Surgery1 yearTo 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.
Maximal Pain Scores - 48 Hours48 hourstotal 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
EVEN Number = PEC Block
Midazolam 0-2 mg IV. NO Fentanyl. 20mL injection below pec minor fascia 10mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 10mL of a mixture of 5mL liposomal bupivacaine and 5mL saline.
56
ODD Number = Surgeon Infiltration
30mL injection beneath pec minor and above serratus anterior or if unable to visualize the serratus/pec minor border will inject under the serratus anterior at the 4th rib 10 mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 20 mL mixture of 15 mL liposomal bupivacaine and 5 mL saline.
55
Total111

Baseline characteristics

CharacteristicEVEN Number = PEC BlockODD Number = Surgeon InfiltrationTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
15 Participants10 Participants25 Participants
Age, Categorical
Between 18 and 65 years
41 Participants45 Participants86 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants1 Participants3 Participants
Race (NIH/OMB)
Asian
2 Participants7 Participants9 Participants
Race (NIH/OMB)
Black or African American
5 Participants2 Participants7 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants1 Participants4 Participants
Race (NIH/OMB)
White
43 Participants44 Participants87 Participants
Sex: Female, Male
Female
56 Participants55 Participants111 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 560 / 55
other
Total, other adverse events
7 / 566 / 55
serious
Total, serious adverse events
0 / 560 / 55

Outcome results

Primary

Total Opioid Use

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

Time frame: time from end of surgery through 72 hours after surgery

ArmMeasureValue (MEDIAN)
EVEN Number = PEC BlockTotal Opioid Use0.0 mg
ODD Number = Surgeon InfiltrationTotal Opioid Use0.0 mg
Secondary

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.

Time frame: 1 year

ArmMeasureValue (MEDIAN)
EVEN Number = PEC BlockEffect in Patients With Breast Surgery2.0 score on a scale
ODD Number = Surgeon InfiltrationEffect in Patients With Breast Surgery4.0 score on a scale
Secondary

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.

Time frame: 1 year

ArmMeasureValue (MEDIAN)
EVEN Number = PEC BlockImproved Quality of Recovery Score142.0 score on a scale
ODD Number = Surgeon InfiltrationImproved Quality of Recovery Score138.0 score on a scale
Secondary

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.

Time frame: 1 hour

ArmMeasureValue (MEDIAN)
EVEN Number = PEC BlockMaximal Pain Scores - 1 Hour1.0 score on a scale
ODD Number = Surgeon InfiltrationMaximal Pain Scores - 1 Hour2.0 score on a scale
Secondary

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.

Time frame: 24 hours

ArmMeasureValue (MEDIAN)
EVEN Number = PEC BlockMaximal Pain Scores - 24 Hours1.0 score on a scale
ODD Number = Surgeon InfiltrationMaximal Pain Scores - 24 Hours2.0 score on a scale
Secondary

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.

Time frame: 2 hours

ArmMeasureValue (MEDIAN)
EVEN Number = PEC BlockMaximal Pain Scores - 2 Hours1.5 score on a scale
ODD Number = Surgeon InfiltrationMaximal Pain Scores - 2 Hours1.0 score on a scale
Secondary

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.

Time frame: 48 hours

ArmMeasureValue (MEDIAN)
EVEN Number = PEC BlockMaximal Pain Scores - 48 Hours1.0 score on a scale
ODD Number = Surgeon InfiltrationMaximal Pain Scores - 48 Hours2.0 score on a scale
Secondary

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.

Time frame: 6 hours

ArmMeasureValue (MEDIAN)
EVEN Number = PEC BlockMaximal Pain Scores - 6 Hours1.0 score on a scale
ODD Number = Surgeon InfiltrationMaximal Pain Scores - 6 Hours2.0 score on a scale
Secondary

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.

Time frame: 72 hours

ArmMeasureValue (MEDIAN)
EVEN Number = PEC BlockMaximal Pain Scores - 72 Hours1.0 score on a scale
ODD Number = Surgeon InfiltrationMaximal Pain Scores - 72 Hours1.0 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026