Trial Outcomes & Findings for Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander (NCT NCT04278846)

NCT ID: NCT04278846

Last Updated: 2022-07-01

Results Overview

Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R) Scale name: Numeric rating scale during rest (NRS-R) The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 50 participants
• Primary outcome timeframe: 1 hour post-operatively
• Results posted on: 2022-07-01

Participant Flow

Participant milestones

Measure	DepoFoam Bupivacaine local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The goal is to have 25 completed patients in each group. Patients that for some reason did not complete the post-operative pain assessment will be replaced. 70 total started but dropout account for difference in overall population

Baseline characteristics by cohort

Measure	DepoFoam Bupivacaine n=25 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=25 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • The goal is to have 25 completed patients in each group. Patients that for some reason did not complete the post-operative pain assessment will be replaced. 70 total started but dropout account for difference in overall population	0 Participants n=7 Participants • The goal is to have 25 completed patients in each group. Patients that for some reason did not complete the post-operative pain assessment will be replaced. 70 total started but dropout account for difference in overall population	0 Participants n=5 Participants • The goal is to have 25 completed patients in each group. Patients that for some reason did not complete the post-operative pain assessment will be replaced. 70 total started but dropout account for difference in overall population
Race (NIH/OMB) Asian	0 Participants n=5 Participants • The goal is to have 25 completed patients in each group. Patients that for some reason did not complete the post-operative pain assessment will be replaced. 70 total started but dropout account for difference in overall population	1 Participants n=7 Participants • The goal is to have 25 completed patients in each group. Patients that for some reason did not complete the post-operative pain assessment will be replaced. 70 total started but dropout account for difference in overall population	1 Participants n=5 Participants • The goal is to have 25 completed patients in each group. Patients that for some reason did not complete the post-operative pain assessment will be replaced. 70 total started but dropout account for difference in overall population
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • The goal is to have 25 completed patients in each group. Patients that for some reason did not complete the post-operative pain assessment will be replaced. 70 total started but dropout account for difference in overall population	0 Participants n=7 Participants • The goal is to have 25 completed patients in each group. Patients that for some reason did not complete the post-operative pain assessment will be replaced. 70 total started but dropout account for difference in overall population	0 Participants n=5 Participants • The goal is to have 25 completed patients in each group. Patients that for some reason did not complete the post-operative pain assessment will be replaced. 70 total started but dropout account for difference in overall population
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants • The goal is to have 25 completed patients in each group. Patients that for some reason did not complete the post-operative pain assessment will be replaced. 70 total started but dropout account for difference in overall population	0 Participants n=7 Participants • The goal is to have 25 completed patients in each group. Patients that for some reason did not complete the post-operative pain assessment will be replaced. 70 total started but dropout account for difference in overall population	1 Participants n=5 Participants • The goal is to have 25 completed patients in each group. Patients that for some reason did not complete the post-operative pain assessment will be replaced. 70 total started but dropout account for difference in overall population
Race (NIH/OMB) White	24 Participants n=5 Participants • The goal is to have 25 completed patients in each group. Patients that for some reason did not complete the post-operative pain assessment will be replaced. 70 total started but dropout account for difference in overall population	24 Participants n=7 Participants • The goal is to have 25 completed patients in each group. Patients that for some reason did not complete the post-operative pain assessment will be replaced. 70 total started but dropout account for difference in overall population	48 Participants n=5 Participants • The goal is to have 25 completed patients in each group. Patients that for some reason did not complete the post-operative pain assessment will be replaced. 70 total started but dropout account for difference in overall population
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • The goal is to have 25 completed patients in each group. Patients that for some reason did not complete the post-operative pain assessment will be replaced. 70 total started but dropout account for difference in overall population	0 Participants n=7 Participants • The goal is to have 25 completed patients in each group. Patients that for some reason did not complete the post-operative pain assessment will be replaced. 70 total started but dropout account for difference in overall population	0 Participants n=5 Participants • The goal is to have 25 completed patients in each group. Patients that for some reason did not complete the post-operative pain assessment will be replaced. 70 total started but dropout account for difference in overall population
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • The goal is to have 25 completed patients in each group. Patients that for some reason did not complete the post-operative pain assessment will be replaced. 70 total started but dropout account for difference in overall population	0 Participants n=7 Participants • The goal is to have 25 completed patients in each group. Patients that for some reason did not complete the post-operative pain assessment will be replaced. 70 total started but dropout account for difference in overall population	0 Participants n=5 Participants • The goal is to have 25 completed patients in each group. Patients that for some reason did not complete the post-operative pain assessment will be replaced. 70 total started but dropout account for difference in overall population
Region of Enrollment United States	25 Participants n=5 Participants • on patients are disqualified based on data collection	25 Participants n=7 Participants • on patients are disqualified based on data collection	50 Participants n=5 Participants • on patients are disqualified based on data collection

PRIMARY outcome

Timeframe: 1 hour post-operatively

Population: All randomized patients

Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R) Scale name: Numeric rating scale during rest (NRS-R) The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain)

Outcome measures

Measure	DepoFoam Bupivacaine n=25 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=25 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
1 Hour Pain Assessment Numeric Rating Scale During Rest	5 units on a scale Interval 3.0 to 6.0	5 units on a scale Interval 3.0 to 6.0

PRIMARY outcome

Timeframe: 8-12 hours post-operatively

Population: All randomized patients

Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R) The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain)

Outcome measures

Measure	DepoFoam Bupivacaine n=25 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=25 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
8-12 Hour Pain Assessment Numeric Rating Scale During Rest	3 units on a scale Interval 2.0 to 4.0	3 units on a scale Interval 2.0 to 4.0

PRIMARY outcome

Timeframe: 24 hours post-operatively

Population: All randomized patients who completed the tools

Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R).

The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain)

Outcome measures

Measure	DepoFoam Bupivacaine n=23 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=24 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
24 Hour Pain Assessment Numeric Rating Scale During Rest	3 units on a scale Interval 2.0 to 5.0	3.5 units on a scale Interval 2.5 to 5.0

PRIMARY outcome

Timeframe: 36 hours post-operatively

Population: All randomized patients who completed the tools

Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R).

The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain)

Outcome measures

Measure	DepoFoam Bupivacaine n=25 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=24 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
36 Hour Pain Assessment Numeric Rating Scale During Rest	3 units on a scale Interval 2.0 to 5.0	3 units on a scale Interval 2.0 to 4.0

PRIMARY outcome

Timeframe: 48 hours post-operatively

Population: All patients who completed tools

Pain will be assessed qualitatively through the use of numeric rating scale during rest (NRS-R).

The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

Outcome measures

Measure	DepoFoam Bupivacaine n=23 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=23 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
48 Hour Pain Assessment Numeric Rating Scale During Rest	3 units on a scale Interval 2.0 to 5.0	3 units on a scale Interval 2.0 to 4.0

PRIMARY outcome

Timeframe: 60 hours post-operatively

Population: All patients who completed tools

Pain will be assessed qualitatively through the use of numeric rating scale during rest (NRS-R).

The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

Outcome measures

Measure	DepoFoam Bupivacaine n=24 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=25 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
60 Hour Pain Assessment Numeric Rating Scale During Rest	3 units on a scale Interval 1.5 to 4.0	2 units on a scale Interval 1.0 to 3.0

PRIMARY outcome

Timeframe: 72 hours post-operatively

Population: All randomized patients

Pain will be assessed qualitatively through the use of numeric rating scale during rest (NRS-R).

The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

Outcome measures

Measure	DepoFoam Bupivacaine n=23 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=25 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
72 Hour Pain Assessment Numeric Rating Scale During Rest	3 units on a scale Interval 1.0 to 4.0	2 units on a scale Interval 1.0 to 3.0

PRIMARY outcome

Timeframe: 84 hours post-operatively

Population: All randomized patients

Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R).

The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

Outcome measures

Measure	DepoFoam Bupivacaine n=21 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=25 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
84 Hour Pain Assessment Numeric Rating Scale During Rest	1 units on a scale Interval 1.0 to 3.0	2 units on a scale Interval 1.0 to 3.0

PRIMARY outcome

Timeframe: 96 hours post-operatively

Population: All randomized patients who completed the tools

Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during rest (NRS-R).

The higher scores indicate more severe pain during rest (10 meaning the worst pain, 0 meaning no pain) Range 0-10

Outcome measures

Measure	DepoFoam Bupivacaine n=20 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=24 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
96 Hour Pain Assessment Numeric Rating Scale During Rest	1.5 units on a scale Interval 0.5 to 2.0	2 units on a scale Interval 1.0 to 3.0

PRIMARY outcome

Timeframe: 36 hours post-operatively

Population: All randomized patients who completed the tools

Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A).

The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

Outcome measures

Measure	DepoFoam Bupivacaine n=18 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=19 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
36 Hour Pain Assessment Numeric Rating Scale During Activity	5 units on a scale Interval 3.0 to 6.0	5 units on a scale Interval 3.0 to 7.0

PRIMARY outcome

Timeframe: 48 hours post-operatively

Population: All randomized patients who completed the tools

Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A).

The higher scores indicate more severe pain during activity (10 meaning the worst pain,0 meaning no pain) The range is 0 to 10.

Outcome measures

Measure	DepoFoam Bupivacaine n=17 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=18 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
48 Hour Pain Assessment Numeric Rating Scale During Activity	4 units on a scale Interval 4.0 to 5.0	5 units on a scale Interval 3.0 to 7.0

PRIMARY outcome

Timeframe: 60 hours post-operatively

Population: All randomized patients who completed the tools

Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A).

The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

Outcome measures

Measure	DepoFoam Bupivacaine n=17 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=19 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
60 Hour Pain Assessment Numeric Rating Scale During Activity	5 units on a scale Interval 2.0 to 6.0	4 units on a scale Interval 2.0 to 7.0

PRIMARY outcome

Timeframe: 72 hours post-operatively

Population: All randomized patients who completed the tools

Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A).

The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

Outcome measures

Measure	DepoFoam Bupivacaine n=16 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=19 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
72 Hour Pain Assessment Numeric Rating Scale During Activity	4 units on a scale Interval 3.0 to 5.5	4 units on a scale Interval 1.0 to 6.0

PRIMARY outcome

Timeframe: 84 hours post-operatively

Population: All randomized patients who completed the tools

Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A).

The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

Outcome measures

Measure	DepoFoam Bupivacaine n=15 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=19 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
84 Hour Pain Assessment Numeric Rating Scale During Activity	4 units on a scale Interval 2.0 to 5.0	3 units on a scale Interval 1.0 to 6.0

PRIMARY outcome

Timeframe: 96 hours post-operatively

Population: All randomized patients who completed the tools

Pain will be assessed qualitatively through the use of numeric rating scale (0-10) during activity (NRS-A).

The higher scores indicate more severe pain during activity (10 meaning the worst pain, 0 meaning no pain) The range is 0 to 10.

Outcome measures

Measure	DepoFoam Bupivacaine n=14 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=18 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
96 Hour Pain Assessment Numeric Rating Scale During Activity	3.5 units on a scale Interval 2.0 to 5.0	3 units on a scale Interval 1.0 to 5.0

PRIMARY outcome

Timeframe: 24 hours post-operatively

Population: All patients who used medication

Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain

Outcome measures

Measure	DepoFoam Bupivacaine n=22 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=23 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
24 Hour Pain Assessment Brief Pain Inventory	4 units on a scale Interval 3.0 to 5.0	5 units on a scale Interval 3.0 to 6.0

PRIMARY outcome

Timeframe: 48 hours post-operatively

Population: All participants who used medication

Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain

Outcome measures

Measure	DepoFoam Bupivacaine n=22 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=24 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
48 Hour Pain Assessment Brief Pain Inventory	3.5 units on a scale Interval 3.0 to 5.0	4 units on a scale Interval 3.0 to 5.0

PRIMARY outcome

Timeframe: 72 hours post-operatively

Population: All participants who used medication

Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain

Outcome measures

Measure	DepoFoam Bupivacaine n=21 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=24 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
72 Hour Pain Assessment Brief Pain Inventory	3 units on a scale Interval 2.0 to 5.0	3 units on a scale Interval 2.0 to 4.5

PRIMARY outcome

Timeframe: 96 hours post-operatively

Population: All participants who used medication

Pain will be assessed qualitatively through the use of the Brief Pain Inventory (BPI) Questionnaire This is also a validated scale from 0 to 10, with 10 having the most severe pain and 0 being no pain

Outcome measures

Measure	DepoFoam Bupivacaine n=22 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=25 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
96 Hour Pain Assessment Brief Pain Inventory	3 units on a scale Interval 2.0 to 4.0	2 units on a scale Interval 2.0 to 4.0

PRIMARY outcome

Timeframe: 96 hours post-operatively

Population: All patients using tools

Pain will be assessed qualitatively through the use of post-operative analgesia patient satisfaction scale (0-5) The higher scores indicate more satisfied patients.( 5 would be very satisfied-less pain, 0 would indicate unsatisfied patients-more pain)

Outcome measures

Measure	DepoFoam Bupivacaine n=20 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=22 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
96 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction 1	0 Participants	1 Participants
96 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction 2	0 Participants	0 Participants
96 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction 3	0 Participants	2 Participants
96 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction 4	9 Participants	11 Participants
96 Hour Pain Assessment Post-Operative Analgesia Patient Satisfaction 5	11 Participants	8 Participants

SECONDARY outcome

Timeframe: 24 hours post operatively

Population: All patients reporting medication use

We will record the amount in milligrams and type of rescue analgesic for each patient.

Outcome measures

Measure	DepoFoam Bupivacaine n=25 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=25 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
24 Hour Use of Rescue Analgesic	63.3 milligrams Standard Deviation 29.3	63.9 milligrams Standard Deviation 47.8

SECONDARY outcome

Timeframe: 48 hours post operatively

Population: All patients reporting medication use

We will record the amount in milligrams and type of rescue analgesic for each patient.

Outcome measures

Measure	DepoFoam Bupivacaine n=25 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=25 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
48 Hour Use of Rescue Analgesic	25.1 milligrams Standard Deviation 21.5	23.3 milligrams Standard Deviation 18.4

SECONDARY outcome

Timeframe: 72 hours post operatively

Population: All patients reporting medication use

We will record the amount in milligrams and type of rescue analgesic for each patient.

Outcome measures

Measure	DepoFoam Bupivacaine n=25 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=25 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
72 Hour Use of Rescue Analgesic	20.7 milligrams Standard Deviation 22.1	19.9 milligrams Standard Deviation 15.6

SECONDARY outcome

Timeframe: 96 hours post operatively

Population: All patients reporting medication use

We will record the amount in milligrams and type of rescue analgesic for each patient.

Outcome measures

Measure	DepoFoam Bupivacaine n=25 Participants local anesthetic Depofoam bupivacaine: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.	Bupivacaine HCl n=25 Participants local anesthetic bupivacaine HCl: The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
96 Hour Use of Rescue Analgesic	10.2 milligrams Standard Deviation 11.4	7.5 milligrams Standard Deviation 9.4

Adverse Events

DepoFoam Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupivacaine HCl

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Raymond Isakov, MD

Cleveland Clinic

Phone: 216 445-3765

Email: ISAKOVR@ccf.org

Results disclosure agreements

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