Trial Outcomes & Findings for Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty (NCT NCT04919317)

NCT ID: NCT04919317

Last Updated: 2023-10-11

Results Overview

Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 56 participants
• Primary outcome timeframe: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)
• Results posted on: 2023-10-11

Participant Flow

Participant milestones

Measure	Control Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
Hospitalization and Wound Follow-up STARTED	26	30
Hospitalization and Wound Follow-up COMPLETED	26	25
Hospitalization and Wound Follow-up NOT COMPLETED	0	5
SF-36 Quality of Life Survey Completion STARTED	26	25
SF-36 Quality of Life Survey Completion COMPLETED	14	19
SF-36 Quality of Life Survey Completion NOT COMPLETED	12	6

Reasons for withdrawal

Measure	Control Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
Hospitalization and Wound Follow-up Protocol Violation	0	5
SF-36 Quality of Life Survey Completion Lost to Follow-up	12	6

Baseline Characteristics

Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty

Baseline characteristics by cohort

Measure	Control n=26 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=25 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Total n=51 Participants Total of all reporting groups
Age, Continuous	38.73 years STANDARD_DEVIATION 13.44 • n=5 Participants	42.48 years STANDARD_DEVIATION 15.17 • n=7 Participants	40.57 years STANDARD_DEVIATION 14.29 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Body Mass Index (BMI)	32.65 kg/m^2 STANDARD_DEVIATION 10.12 • n=5 Participants	34.12 kg/m^2 STANDARD_DEVIATION 13.99 • n=7 Participants	33.37 kg/m^2 STANDARD_DEVIATION 12.07 • n=5 Participants
Anemia	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Anxiety	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Asthma	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Depression	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Degenerative Disc Disease	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Degenerative Joint Disease	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Diabetes	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Drug Abuse	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Gastroesophaageal reflux disease (GERD)	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Hypothyroidism	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Hyperlipidemia	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Human immunodeficiency virus infection (HIV) / Acquired immunodeficiency syndrome AIDS	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Hypertension	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Insomnia	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Migraines	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Polycystic ovaries	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Uterine Fibroids	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Abnormal Uterine Bleeding	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Rheumatoid Arthritis	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)

Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

Outcome measures

Measure	Control n=26 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=25 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
Initial Visual Analog Scale (VAS) Pain Scores	8.3 score on a scale Standard Deviation 1.5	7.4 score on a scale Standard Deviation 2.1

PRIMARY outcome

Timeframe: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)

Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

Outcome measures

Measure	Control n=26 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=25 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
4-hour Visual Analog Scale (VAS) Pain Scores	5.5 score on a scale Standard Deviation 3.5	4.6 score on a scale Standard Deviation 3.6

PRIMARY outcome

Timeframe: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)

Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

Outcome measures

Measure	Control n=26 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=25 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
8-hour Visual Analog Scale (VAS) Pain Scores	4.4 score on a scale Standard Deviation 3.9	3.5 score on a scale Standard Deviation 3.6

PRIMARY outcome

Timeframe: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)

Population: Between the prior time point and this time point, 8 patients from the experimental group had been discharged to home

Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

Outcome measures

Measure	Control n=26 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=17 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
12-hour Visual Analog Scale (VAS) Pain Scores	3.9 score on a scale Standard Deviation 3.7	3.4 score on a scale Standard Deviation 3.6

PRIMARY outcome

Timeframe: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)

Population: Between the prior time point and this time point, 9 patients in the control group and 2 patients from the experimental group had been discharged to home

Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

Outcome measures

Measure	Control n=17 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=15 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
16-hour Visual Analog Scale (VAS) Pain Scores	5.6 score on a scale Standard Deviation 2.8	5.4 score on a scale Standard Deviation 2.8

PRIMARY outcome

Timeframe: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)

Population: Between the prior time point and this time point, 7 patients in the control group and 4 patients from the experimental group had been discharged to home

Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

Outcome measures

Measure	Control n=10 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=11 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
20-hour Visual Analog Scale (VAS) Pain Scores	5.8 score on a scale Standard Deviation 3.4	4.9 score on a scale Standard Deviation 3.8

PRIMARY outcome

Timeframe: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)

Population: Between the prior time point and this time point, 4 patients in the control group and 6 patients from the experimental group had been discharged to home

Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain)

Outcome measures

Measure	Control n=6 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=5 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
24-hour Visual Analog Scale (VAS) Pain Scores	5.2 score on a scale Standard Deviation 3.8	8 score on a scale Standard Deviation 1.4

PRIMARY outcome

Timeframe: Up to 24 hours postoperatively

Mean narcotics used by each patient while in the hospital during the 24-hour hospitalization

Outcome measures

Measure	Control n=26 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=25 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
Narcotic Consumption	36.60 Oral Morphine Equivalents (OME) Standard Deviation 23.99	23.19 Oral Morphine Equivalents (OME) Standard Deviation 17.26

SECONDARY outcome

Timeframe: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)

Systolic blood pressure

Outcome measures

Measure	Control n=24 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=25 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
Initial Blood Pressure	124.2 mmHg Standard Deviation 14.8	123.8 mmHg Standard Deviation 13.5

SECONDARY outcome

Timeframe: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)

Systolic blood pressure

Outcome measures

Measure	Control n=18 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=19 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
4-hour Blood Pressure	118.0 mmHg Standard Deviation 10.8	119.6 mmHg Standard Deviation 16.4

SECONDARY outcome

Timeframe: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)

Systolic blood pressure

Outcome measures

Measure	Control n=20 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=19 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
8-hour Blood Pressure	113.8 mmHg Standard Deviation 12.2	117.9 mmHg Standard Deviation 17.4

SECONDARY outcome

Timeframe: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)

Systolic blood pressure

Outcome measures

Measure	Control n=18 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=23 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
12-hour Blood Pressure	106.7 mmHg Standard Deviation 8.6	112.0 mmHg Standard Deviation 17.8

SECONDARY outcome

Timeframe: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)

Systolic blood pressure

Outcome measures

Measure	Control n=16 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=19 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
16-hour Blood Pressure	112.3 mmHg Standard Deviation 13.6	104.2 mmHg Standard Deviation 8.0

SECONDARY outcome

Timeframe: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)

Systolic blood pressure

Outcome measures

Measure	Control n=13 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=15 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
20-hour Blood Pressure	106.5 mmHg Standard Deviation 12.5	114.7 mmHg Standard Deviation 9.6

SECONDARY outcome

Timeframe: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)

Systolic blood pressure

Outcome measures

Measure	Control n=3 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=3 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
24-hour Blood Pressure	108.7 mmHg Standard Deviation 8.5	118.3 mmHg Standard Deviation 24.5

SECONDARY outcome

Timeframe: Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU)

SpO2 as measured by pulse oximetry

Outcome measures

Measure	Control n=23 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=23 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
Initial Oxygen Saturation	99.4 percentage of blood oxygen saturation Standard Deviation 1.1	98.6 percentage of blood oxygen saturation Standard Deviation 2.1

SECONDARY outcome

Timeframe: Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU)

SpO2 as measured by pulse oximetry

Outcome measures

Measure	Control n=18 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=19 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
4-hour Oxygen Saturation	97.8 percentage of blood oxygen saturation Standard Deviation 1.6	96.9 percentage of blood oxygen saturation Standard Deviation 1.7

SECONDARY outcome

Timeframe: Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU)

SpO2 as measured by pulse oximetry

Outcome measures

Measure	Control n=20 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=19 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
8-hour Oxygen Saturation	98.7 percentage of blood oxygen saturation Standard Deviation 1.4	96.5 percentage of blood oxygen saturation Standard Deviation 2.0

SECONDARY outcome

Timeframe: Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU)

SpO2 as measured by pulse oximetry

Outcome measures

Measure	Control n=18 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=23 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
12-hour Oxygen Saturation	97.8 percentage of blood oxygen saturation Standard Deviation 1.5	97.0 percentage of blood oxygen saturation Standard Deviation 2.1

SECONDARY outcome

Timeframe: Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU)

SpO2 as measured by pulse oximetry

Outcome measures

Measure	Control n=16 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=19 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
16-hour Oxygen Saturation	98.8 percentage of blood oxygen saturation Standard Deviation 1.2	96.9 percentage of blood oxygen saturation Standard Deviation 1.6

SECONDARY outcome

Timeframe: Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU)

SpO2 as measured by pulse oximetry

Outcome measures

Measure	Control n=12 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=13 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
20-hour Oxygen Saturation	99.0 percentage of blood oxygen saturation Standard Deviation 0.9	98.3 percentage of blood oxygen saturation Standard Deviation 1.9

SECONDARY outcome

Timeframe: Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU)

SpO2 as measured by pulse oximetry

Outcome measures

Measure	Control n=3 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=3 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
24-hour Oxygen Saturation	99.3 percentage of blood oxygen saturation Standard Deviation 0.6	97.3 percentage of blood oxygen saturation Standard Deviation 3.1

SECONDARY outcome

Timeframe: Initial, 4, 8, 12, 16, 20, and 24 hours

Frequency of anti-emetics administered for complaints of nausea or vomiting at 4-hour intervals

Outcome measures

Measure	Control n=26 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=25 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
Number of Patients Administered Anti-emetics at 4-hour Intervals 4-hours postoperatively	7 Participants	2 Participants
Number of Patients Administered Anti-emetics at 4-hour Intervals 8-hours postoperatively	2 Participants	1 Participants
Number of Patients Administered Anti-emetics at 4-hour Intervals 12-hours postoperatively	4 Participants	0 Participants
Number of Patients Administered Anti-emetics at 4-hour Intervals 16-hours postoperatively	0 Participants	0 Participants
Number of Patients Administered Anti-emetics at 4-hour Intervals 20-hours postoperatively	0 Participants	0 Participants
Number of Patients Administered Anti-emetics at 4-hour Intervals 24-hours postoperatively	0 Participants	0 Participants
Number of Patients Administered Anti-emetics at 4-hour Intervals Initial	4 Participants	5 Participants

SECONDARY outcome

Timeframe: 1 week to 2 months postoperatively

Aggregate results of the sf-36 quality of life assessment. This was provided one time to each patient, as early as at the first postoperative visit or at any time thereafter up to 2 months postoperatively. This assessment has been validated to measure 8 categories related to quality of life: physical functioning, limitations due to physical health, limitations due to emotional health, perceived level of energy/fatigue, emotional well-being, social functioning, pain, and overall general health. The responses to the 36 questions are tabulated and each category is given a score from 1-100 for each individual patient. Higher scores indicate a better quality of life for that category. The rows/data below report the mean and standard deviations of the collected scores in each category.

Outcome measures

Measure	Control n=14 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=19 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
Short-form 36-item (Sf-36) Quality of Life Questionnaire Physical Functioning	88.93 score on a scale Standard Deviation 15.83	90.42 score on a scale Standard Deviation 13.98
Short-form 36-item (Sf-36) Quality of Life Questionnaire Limitations Due to Emotional Health	88.10 score on a scale Standard Deviation 28.06	80.56 score on a scale Standard Deviation 32.04
Short-form 36-item (Sf-36) Quality of Life Questionnaire Energy/Fatigue	54.64 score on a scale Standard Deviation 12.63	52.92 score on a scale Standard Deviation 16.61
Short-form 36-item (Sf-36) Quality of Life Questionnaire Emotional Well-being	65.71 score on a scale Standard Deviation 6.41	59.00 score on a scale Standard Deviation 13.16
Short-form 36-item (Sf-36) Quality of Life Questionnaire Social Functioning	92.50 score on a scale Standard Deviation 9.71	88.75 score on a scale Standard Deviation 16.70
Short-form 36-item (Sf-36) Quality of Life Questionnaire Pain	59.64 score on a scale Standard Deviation 35.84	64.42 score on a scale Standard Deviation 25.16
Short-form 36-item (Sf-36) Quality of Life Questionnaire Overall General Health	51.43 score on a scale Standard Deviation 13.36	56.25 score on a scale Standard Deviation 13.69
Short-form 36-item (Sf-36) Quality of Life Questionnaire Limitations Due to Physical Health	82.14 score on a scale Standard Deviation 24.86	79.17 score on a scale Standard Deviation 32.61

SECONDARY outcome

Timeframe: 1 week to 2 months postoperatively

Assessment of wound complications during any postoperative clinic visit

Outcome measures

Measure	Control n=26 Participants Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=25 Participants Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
Rate of Wound Complications None	19 Participants	19 Participants
Rate of Wound Complications Minor	5 Participants	3 Participants
Rate of Wound Complications Moderate	2 Participants	2 Participants
Rate of Wound Complications Severe	0 Participants	1 Participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Experimental

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Control n=26 participants at risk Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.	Experimental n=25 participants at risk Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
Surgical and medical procedures Wound complications	26.9% 7/26 • 2 months postoperatively Other adverse event: wound complications of any severity	32.0% 8/25 • 2 months postoperatively Other adverse event: wound complications of any severity

Additional Information

George Taylor, MD, MS; surgical resident

Temple University Hospital

Phone: 2678150512

Email: George.Taylor@tuhs.temple.edu

Results disclosure agreements

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