Trial Outcomes & Findings for Evaluation of the Safety and Efficacy of EXPAREL When Administered Into the TAP in Subjects Undergoing Cesarean Section (NCT NCT02353754)

Results Overview

Outcome measure data refer to 7 participants who received rescue medication

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

Through 72 hours postdose

Results posted on

2021-03-26

Participant Flow

Participant milestones

Participant milestones
Measure	Standard of Care Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. Intrathecal morphine injection: 0.2 mg	EXPAREL/TAP Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen). EXPAREL: 266 mg
Overall Study STARTED	12	0
Overall Study COMPLETED	10	0
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Safety and Efficacy of EXPAREL When Administered Into the TAP in Subjects Undergoing Cesarean Section

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care n=12 Participants Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. Intrathecal morphine injection: 0.2 mg	EXPAREL/TAP Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen). EXPAREL: 266 mg	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	—	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Continuous	32.2 years STANDARD_DEVIATION 4.71 • n=5 Participants	—	32.2 years STANDARD_DEVIATION 4.71 • n=5 Participants
Sex/Gender, Customized Female	12 participants n=5 Participants	—	12 participants n=5 Participants
Sex/Gender, Customized Male	0 participants n=5 Participants	—	0 participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	—	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Through 72 hours postdose

Population: The study was terminated due to slow enrollment after 12 subjects were assigned to Group 1 (Standard of Care/Duramorph). As no subjects were enrolled into Group 2 (EXPAREL/TAP), no conclusions can be drawn regarding the study endpoints.

Outcome measure data refer to 7 participants who received rescue medication

Outcome measures

Outcome measures
Measure	Standard of Care n=12 Participants Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. Intrathecal morphine injection: 0.2 mg	EXPAREL/TAP Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen). EXPAREL: 266 mg
Total Postsurgical Narcotic Consumption in Morphine Equivalents	6.1 MUEs Standard Deviation 3.67	—

SECONDARY outcome

Timeframe: Through 24 hours

Population: The study was terminated due to slow enrollment after 12 subjects were assigned to Group 1 (Standard of Care/Duramorph). As no subjects were enrolled into Group 2 (EXPAREL/TAP), no conclusions can be drawn regarding the study endpoints.

Outcome measure data refer to 6 participants who received rescue medication

Outcome measures

Outcome measures
Measure	Standard of Care n=12 Participants Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. Intrathecal morphine injection: 0.2 mg	EXPAREL/TAP Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen). EXPAREL: 266 mg
Total Postsurgical Narcotic Consumption in Morphine Equivalents	4.9 MUEs Standard Deviation 2.01	—

SECONDARY outcome

Timeframe: Through 48 hours

Population: The study was terminated due to slow enrollment after 12 subjects were assigned to Group 1 (Standard of Care/Duramorph). As no subjects were enrolled into Group 2 (EXPAREL/TAP), no conclusions can be drawn regarding the study endpoints.

Outcome measure data refer to 7 participants who received rescue medication

Outcome measures

Outcome measures
Measure	Standard of Care n=12 Participants Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. Intrathecal morphine injection: 0.2 mg	EXPAREL/TAP Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen). EXPAREL: 266 mg
Total Postsurgical Narcotic Consumption in Morphine Equivalents	6.1 MUEs Standard Deviation 3.67	—

Adverse Events

Standard of Care

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

EXPAREL/TAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Standard of Care n=12 participants at risk Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. Intrathecal morphine injection: 0.2 mg	EXPAREL/TAP Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen). EXPAREL: 266 mg
Infections and infestations oral herpes	8.3% 1/12 • Number of events 1	— 0/0
Injury, poisoning and procedural complications bladder injury	8.3% 1/12 • Number of events 1	— 0/0

Additional Information

James B. Jones, MD, PharmD

Pacira Pharmaceuticals Inc.

Phone: (973) 254-3560

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place