Trial Outcomes & Findings for Pec Infiltration With Liposomal Bupivacaine for Breast Surgery (NCT NCT03599635)

NCT ID: NCT03599635

Last Updated: 2025-12-11

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 112 participants
• Primary outcome timeframe: time from end of surgery through 72 hours after surgery
• Results posted on: 2025-12-11

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	56	55
Overall Study COMPLETED	56	55
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pec Infiltration With Liposomal Bupivacaine for Breast Surgery

Baseline characteristics by cohort

Measure	EVEN Number = PEC Block n=56 Participants 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.	ODD Number = Surgeon Infiltration n=55 Participants 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.	Total n=111 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=237 Participants	0 Participants n=243 Participants	0 Participants n=480 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=237 Participants	45 Participants n=243 Participants	86 Participants n=480 Participants
Age, Categorical >=65 years	15 Participants n=237 Participants	10 Participants n=243 Participants	25 Participants n=480 Participants
Sex: Female, Male Female	56 Participants n=237 Participants	55 Participants n=243 Participants	111 Participants n=480 Participants
Sex: Female, Male Male	0 Participants n=237 Participants	0 Participants n=243 Participants	0 Participants n=480 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=237 Participants	1 Participants n=243 Participants	3 Participants n=480 Participants
Race (NIH/OMB) Asian	2 Participants n=237 Participants	7 Participants n=243 Participants	9 Participants n=480 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=237 Participants	0 Participants n=243 Participants	1 Participants n=480 Participants
Race (NIH/OMB) Black or African American	5 Participants n=237 Participants	2 Participants n=243 Participants	7 Participants n=480 Participants
Race (NIH/OMB) White	43 Participants n=237 Participants	44 Participants n=243 Participants	87 Participants n=480 Participants
Race (NIH/OMB) More than one race	0 Participants n=237 Participants	0 Participants n=243 Participants	0 Participants n=480 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=237 Participants	1 Participants n=243 Participants	4 Participants n=480 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	EVEN Number = PEC Block n=56 Participants 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.	ODD Number = Surgeon Infiltration n=52 Participants 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.
Total Opioid Use	0.0 mg Interval 0.0 to 0.0	0.0 mg Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	EVEN Number = PEC Block n=56 Participants 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.	ODD Number = Surgeon Infiltration n=52 Participants 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.
Maximal Pain Scores - 1 Hour	1.0 score on a scale Interval 0.0 to 4.0	2.0 score on a scale Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	EVEN Number = PEC Block n=56 Participants 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.	ODD Number = Surgeon Infiltration n=52 Participants 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.
Maximal Pain Scores - 2 Hours	1.5 score on a scale Interval 0.0 to 3.0	1.0 score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	EVEN Number = PEC Block n=56 Participants 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.	ODD Number = Surgeon Infiltration n=52 Participants 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.
Maximal Pain Scores - 6 Hours	1.0 score on a scale Interval 0.0 to 2.3	2.0 score on a scale Interval 1.0 to 3.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	EVEN Number = PEC Block n=56 Participants 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.	ODD Number = Surgeon Infiltration n=52 Participants 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.
Maximal Pain Scores - 24 Hours	1.0 score on a scale Interval 0.0 to 3.0	2.0 score on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	EVEN Number = PEC Block n=56 Participants 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.	ODD Number = Surgeon Infiltration n=52 Participants 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.
Maximal Pain Scores - 48 Hours	1.0 score on a scale Interval 0.0 to 3.0	2.0 score on a scale Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	EVEN Number = PEC Block n=56 Participants 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.	ODD Number = Surgeon Infiltration n=52 Participants 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.
Maximal Pain Scores - 72 Hours	1.0 score on a scale Interval 0.0 to 2.0	1.0 score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: 1 year

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.

Outcome measures

Measure	EVEN Number = PEC Block n=56 Participants 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.	ODD Number = Surgeon Infiltration n=52 Participants 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.
Improved Quality of Recovery Score	142.0 score on a scale Interval 132.0 to 148.0	138.0 score on a scale Interval 130.0 to 143.5

SECONDARY outcome

Timeframe: 1 year

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.

Outcome measures

Measure	EVEN Number = PEC Block n=56 Participants 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.	ODD Number = Surgeon Infiltration n=52 Participants 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.
Effect in Patients With Breast Surgery	2.0 score on a scale Interval 0.0 to 4.0	4.0 score on a scale Interval 1.0 to 5.0

Adverse Events

EVEN Number = PEC Block

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

ODD Number = Surgeon Infiltration

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	EVEN Number = PEC Block n=56 participants at risk 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.	ODD Number = Surgeon Infiltration n=55 participants at risk 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.
Gastrointestinal disorders Nausea/ Vomiting	12.5% 7/56 • Number of events 7 • One year	10.9% 6/55 • Number of events 6 • One year

Additional Information

Jason Habeck

University of Minnesota

Phone: 612-624-9990

Email: habe0073@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place