Trial Outcomes & Findings for EXPAREL Infiltrated Into the TAP for Postoperative Analgesia in Unilateral Abdominal Hernia Repair (NCT NCT01801124)

Results Overview

The effectiveness of abdominal analgesia from the infiltration into the TAP as measured by the subject's overall postsurgical analgesic use in morphine equivalents (mg)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

13 participants

Primary outcome timeframe

10 days

Results posted on

2021-03-08

Participant Flow

Recruitment occurred between 20 July 2012 and 27 November 2012 at one site in the USA.

Subjects were not excluded.

Participant milestones

Participant milestones
Measure	EXPAREL All subjects received a total of 266mg EXPAREL (bupicavaine liposome injectable suspension) diluted with preservative-free 0.9% normal saline to a volume of 30mL. Study drug was to be administered with ultrasound guidance by injection through a needle or catheter into the tissue plane between the transversus abdominis and internal oblique muscles of the abdominal wall.
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

EXPAREL Infiltrated Into the TAP for Postoperative Analgesia in Unilateral Abdominal Hernia Repair

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EXPAREL n=13 Participants undiluted EXPAREL 266 mg
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	45.7 years STANDARD_DEVIATION 12.72 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 days

Population: The analysis population comprised all enrolled subjects.

The effectiveness of abdominal analgesia from the infiltration into the TAP as measured by the subject's overall postsurgical analgesic use in morphine equivalents (mg)

Outcome measures

Outcome measures
Measure	EXPAREL n=13 Participants Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs.
Overall Postsurgical Analgesic Use	9.7 mg (morphine equivalents) Standard Deviation 17.41

SECONDARY outcome

Timeframe: 30 days

Population: The analysis population comprised all enrolled subjects.

Adverse events and serious adverse events through Day 30 will be examined in order to assess the safety of EXPAREL.

Outcome measures

Outcome measures
Measure	EXPAREL n=13 Participants Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs.
Postsurgical AEs and SAEs Through Day 30.	0 AEs

Adverse Events

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

Mark Kronefeld, MD

Maimonides Medical Center

Phone: (718) 283-8816

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place