Trial Outcomes & Findings for EXPAREL Administered by Infiltration Into the TAP for Prolonged Postsurgical Analgesia in Lower Abdominal Surgeries (NCT NCT01919190)

Results Overview

Total Opioid Consumption Post Surgery (cumulative total) Until Discharge Readiness or Post Surgery Day 4

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

67 participants

Primary outcome timeframe

From surgery through 4 days postsurgery

Results posted on

2021-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	EXPAREL EXPAREL (266 mg/20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP. EXPAREL	Placebo The placebo control was established using a grade-2 sham; no infiltration occurred. Placebo
Overall Study STARTED	33	34
Overall Study COMPLETED	30	34
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	EXPAREL EXPAREL (266 mg/20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP. EXPAREL	Placebo The placebo control was established using a grade-2 sham; no infiltration occurred. Placebo
Overall Study Intra-op findings, etc.	3	0

Baseline Characteristics

EXPAREL Administered by Infiltration Into the TAP for Prolonged Postsurgical Analgesia in Lower Abdominal Surgeries

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EXPAREL n=33 Participants EXPAREL (266 mg/20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP. EXPAREL	Placebo n=34 Participants The placebo control was established using a grade-2 sham; no infiltration occurred. Placebo	Total n=67 Participants Total of all reporting groups
Age, Customized Under 75	32 participants n=5 Participants	33 participants n=7 Participants	65 participants n=5 Participants
Age, Customized Over 75	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	28 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	34 participants n=7 Participants	67 participants n=5 Participants

PRIMARY outcome

Timeframe: From surgery through 4 days postsurgery

Total Opioid Consumption Post Surgery (cumulative total) Until Discharge Readiness or Post Surgery Day 4

Outcome measures

Outcome measures
Measure	EXPAREL n=33 Participants EXPAREL (266 mg/20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP EXPAREL	Placebo n=34 Participants The placebo control will be established using a grade-2 sham, no infiltration will occur Placebo
Total Opioid Consumption Post Surgery (Cumulative Total) Until Discharge Readiness or Post Surgery Day 4	3.79 Opioid consumption (mg) Standard Error NA All efforts have been made to obtain the raw data but it cannot be located and a Measure of Dispersion cannot be calculated. The analysis was performed years ago, all data available have been entered.	3.72 Opioid consumption (mg) Standard Error NA All efforts have been made to obtain the raw data but it cannot be located and a Measure of Dispersion cannot be calculated. The analysis was performed years ago, all data available have been entered.

PRIMARY outcome

Timeframe: Postsurgical day 1 through day 3

Severity of postsurgical pain, satisfaction with pain management, and impact of opioid-related symptom distress measured using the Overall Benefit of Analgesic Score (OBAS) - primary endpoint is mean difference in OBAS at Day 3. (0=minimal pain and 4=maximum imaginable pain)

Outcome measures

Outcome measures
Measure	EXPAREL n=33 Participants EXPAREL (266 mg/20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP EXPAREL	Placebo n=34 Participants The placebo control will be established using a grade-2 sham, no infiltration will occur Placebo
Overall Benefit of Analgesic Score (OBAS) at Day 3	3.05 units on a scale Standard Error 0.56	4.63 units on a scale Standard Error 0.56

SECONDARY outcome

Timeframe: Prior to TAP, immediately postoperatively, and daily through discharge or Day 4

Population: The analysis was not conducted due to the early termination of this study.

Extent and degree of anesthetic blockage measured using a 5-point sensation scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Immediately in PACU postsurgery and prior to pain medication until discharge (or Day 4)

Population: The analysis was not conducted due to the early termination of this study.

Severity of postsurgical pain measured using an 11-point numerical rating scale (NRS 0-10).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Daily through Post Op Day 4

Population: The analysis was not conducted due to the early termination of this study.

Measured using the Quality of Recovery 15 questionnaire (QoR-15)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post-discharge through 4 days postsurgery

Population: The analysis was not conducted due to the early termination of this study.

Frequency of patient calls post-discharge related to pain and unscheduled hospital/surgeon visits

Outcome measures

Outcome data not reported

Adverse Events

EXPAREL

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	EXPAREL n=33 participants at risk EXPAREL (266 mg/20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP EXPAREL	Placebo n=34 participants at risk The placebo control will be established using a grade-2 sham, no infiltration will occur Placebo
Blood and lymphatic system disorders Postoperative anemia exacerbation	0.00% 0/33 • 10 days	2.9% 1/34 • Number of events 1 • 10 days
Investigations Subtherapeutic international normalized ration (INR)	0.00% 0/33 • 10 days	2.9% 1/34 • Number of events 1 • 10 days
Gastrointestinal disorders Postoperative abdominal hemorrhage	3.0% 1/33 • Number of events 1 • 10 days	0.00% 0/34 • 10 days

Other adverse events

Adverse event data not reported

Additional Information

Paci

Pacira Pharmaceuticals, Inc.

Phone: 1-855-793-9727

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place