Trial Outcomes & Findings for EXPAREL Administered Into the TAP for Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy (NCT NCT01919606)

NCT ID: NCT01919606

Last Updated: 2021-03-02

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 1 participants
• Primary outcome timeframe: End of surgery to time of subject's first postsurgical opioid administration (through 72 hours)
• Results posted on: 2021-03-02

Participant Flow

Participant milestones

Measure	EXPAREL Group 1 EXPAREL 266 mg diluted with saline to a volume of 40 mL EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.	EXPAREL Group 2 EXPAREL 266 mg diluted with saline to a volume of 60 mL EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

EXPAREL Administered Into the TAP for Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy

Baseline characteristics by cohort

Measure	EXPAREL Group 1 n=1 Participants EXPAREL 266 mg diluted with saline to a volume of 40 mL EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.	EXPAREL Group 2 EXPAREL 266 mg diluted with saline to a volume of 60 mL EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.	Total n=1 Participants Total of all reporting groups
Age, Continuous	67 years STANDARD_DEVIATION 0 • n=5 Participants	—	67 years STANDARD_DEVIATION 0 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	1 participants n=5 Participants

PRIMARY outcome

Timeframe: End of surgery to time of subject's first postsurgical opioid administration (through 72 hours)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 days post surgery plus or minus 3 days

Outcome measures

Measure	EXPAREL Group 1 n=1 Participants EXPAREL 266 mg diluted with saline to a volume of 40 mL EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.	EXPAREL Group 2 EXPAREL 266 mg diluted with saline to a volume of 60 mL EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.
Incidence of Adverse Events	0 number of events	—

Adverse Events

EXPAREL Group 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

EXPAREL Group 1

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

Pacira Medical Information

Pacira Pharmaceuticals, Inc.

Phone: 1-855-793-9727

Email: MedInfo@pacira.com

Results disclosure agreements

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