Trial Outcomes & Findings for Study of EXPAREL in Patients Undergoing Breast Augmentation (NCT NCT01582490)

NCT ID: NCT01582490

Last Updated: 2014-07-02

Results Overview

The primary outcome measure is the duration of analgesia, measured by the time (hours) from the end surgery to the subject's first postsurgical opioid administration.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 19 participants
• Primary outcome timeframe: 10 days
• Results posted on: 2014-07-02

Participant Flow

Participant milestones

Measure	Infiltration - EXPAREL Subjects received EXPAREL 266 mg via infiltration.	Instillation - EXPAREL Subjects received EXPAREL 266 mg via instillation.
Overall Study STARTED	9	10
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of EXPAREL in Patients Undergoing Breast Augmentation

Baseline characteristics by cohort

Measure	Infiltration - EXPAREL n=9 Participants Group 2 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be administered via local infiltration into each surgical site per the surgeon's normal practice at the beginning of surgery. Instillation - EXPAREL: Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.	Instillation - EXPAREL n=10 Participants Group 1 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be instilled into each breast pocket at the beginning of surgery. Infiltration - EXPAREL: IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.	Total n=19 Participants Total of all reporting groups
Age, Continuous	27.8 years STANDARD_DEVIATION 7.25 • n=5 Participants	29.7 years STANDARD_DEVIATION 11.41 • n=7 Participants	28.8 years STANDARD_DEVIATION 9.57 • n=5 Participants
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	9 Participants n=5 Participants	10 Participants n=7 Participants	19 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	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	10 participants n=7 Participants	19 participants n=5 Participants
ASA Classification ASA Class 1	5 participants n=5 Participants	9 participants n=7 Participants	14 participants n=5 Participants
ASA Classification ASA Class 2	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 days

Population: Of the 8 subjects in the Infiltration - EXPAREL group (efficacy analysis set), 5 were censored, leaving 3 subjects who were administered an opioid. Of the 9 subjects in the Instillation - EXPAREL group (efficacy analysis set), 7 were censored, leaving 2 subjects who were administered an opioid.

The primary outcome measure is the duration of analgesia, measured by the time (hours) from the end surgery to the subject's first postsurgical opioid administration.

Outcome measures

Measure	Infiltration - EXPAREL n=3 Participants Subjects received EXPAREL 266 mg via infiltration.	Instillation - EXPAREL n=2 Participants Subjects received EXPAREL 266 mg via instillation.
Duration of Analgesia Minimum time to postsurgical opioid	0.07 hours	0.3 hours
Duration of Analgesia Maximum time to postsurgical opioid	4.28 hours	4.82 hours

SECONDARY outcome

Timeframe: 10 days

Population: There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.

Total amount of opioids (morphine-equivalent mg) administered postsurgically in each group.

Outcome measures

Measure	Infiltration - EXPAREL n=8 Participants Subjects received EXPAREL 266 mg via infiltration.	Instillation - EXPAREL n=9 Participants Subjects received EXPAREL 266 mg via instillation.
Total Postsurgical Opioid Consumption in the Surgical Center	4.5 mg Standard Deviation 6.26	3.0 mg Standard Deviation 7.74

SECONDARY outcome

Timeframe: Upon waking in the PACO post surgery

Population: There were 9 subjects in the Infiltration - EXPAREL efficacy analysis set and 8 subjects in the Instillation - EXPAREL efficacy analysis set.

Subject-reported pain assessment upon waking in the PACU on a scale of 0 to 10 where 0 = no pain and 10 = worst possible pain.

Outcome measures

Measure	Infiltration - EXPAREL n=8 Participants Subjects received EXPAREL 266 mg via infiltration.	Instillation - EXPAREL n=9 Participants Subjects received EXPAREL 266 mg via instillation.
Pain Intensity Assessment Upon Waking in the PACU	4.5 units on a scale Standard Deviation 2.98	3.7 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: At the time of hospital discharge

Population: There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.

Subject-reported pain assessment at the time of hospital discharge (assessed an average of 3.11 hours after surgery for the Instillation group and 3.20 hours after surgery for the Infiltration group) on a scale from 0 to 10 where 0 = no pain and 10 = worst possible pain.

Outcome measures

Measure	Infiltration - EXPAREL n=8 Participants Subjects received EXPAREL 266 mg via infiltration.	Instillation - EXPAREL n=9 Participants Subjects received EXPAREL 266 mg via instillation.
Pain Intensity Assessment at the Time of Hospital Discharge	3.8 units on a scale Standard Deviation 1.39	3.4 units on a scale Standard Deviation 1.88

SECONDARY outcome

Timeframe: At the time of hospital discharge

Population: There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.

The time (hours) to the hospital discharge being written for subjects in each group,

Outcome measures

Measure	Infiltration - EXPAREL n=8 Participants Subjects received EXPAREL 266 mg via infiltration.	Instillation - EXPAREL n=9 Participants Subjects received EXPAREL 266 mg via instillation.
Time to Hospital Discharge Being Written	3.2 hours Standard Deviation 0.941	3.11 hours Standard Deviation 1.005

SECONDARY outcome

Timeframe: Through 10 Days Post Surgery

Population: There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.

The incidence of adverse events that were assessed as opioid-related

Outcome measures

Measure	Infiltration - EXPAREL n=8 Participants Subjects received EXPAREL 266 mg via infiltration.	Instillation - EXPAREL n=9 Participants Subjects received EXPAREL 266 mg via instillation.
Incidence of Opioid-Related Adverse Events	0 participants	0 participants

SECONDARY outcome

Timeframe: At the time of hospital discharge

Population: There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.

Subject-reported satisfaction with postsurgical pain control in the categories of "extremely dissatisfied," "dissatisfied," "neither satisfied nor dissatisfied," "satisfied," and "extremely satisfied."

Outcome measures

Measure	Infiltration - EXPAREL n=8 Participants Subjects received EXPAREL 266 mg via infiltration.	Instillation - EXPAREL n=9 Participants Subjects received EXPAREL 266 mg via instillation.
Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Hospital Discharge Extremely Dissatisfied	1 participants	0 participants
Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Hospital Discharge Dissatisfied	1 participants	0 participants
Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Hospital Discharge Neither Satisfied nor Dissatisfied	0 participants	2 participants
Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Hospital Discharge Satisfied	3 participants	3 participants
Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Hospital Discharge Extremely Satisfied	3 participants	4 participants

SECONDARY outcome

Timeframe: Day 10 after surgery

Population: There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.

Subject-reported satisfaction with postsurgical pain control in the categories of "extremely dissatisfied," "dissatisfied," "neither satisfied nor dissatisfied," "satisfied," and "extremely satisfied."

Outcome measures

Measure	Infiltration - EXPAREL n=8 Participants Subjects received EXPAREL 266 mg via infiltration.	Instillation - EXPAREL n=9 Participants Subjects received EXPAREL 266 mg via instillation.
Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Day 10 Satisfied	2 participants	2 participants
Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Day 10 Extremely Satisfied	2 participants	5 participants
Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Day 10 Extremely Dissatisfied	2 participants	0 participants
Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Day 10 Dissatisfied	1 participants	0 participants
Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Day 10 Neither Satisfied nor Dissatisfied	1 participants	2 participants

Adverse Events

Infiltration - EXPAREL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Instillation - EXPAREL

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

Erol Onel, MD

Pacira Pharmaceuticals, Inc.

Phone: 858-625-2424

Email: erol.onel@pacira.com

Results disclosure agreements

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