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

• Sponsor: Pacira Pharmaceuticals, Inc (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01919606
• Collaborator: (none)
• Enrollment: 1
• Arms: 2
• Duration (Months): 2

Study Details

Study Description

Brief Summary

The primary objective of this study is to determine the optimal of two different volumes of EXPAREL 266 mg when administered via infiltration into the transversus abdominis plane (TAP) for prolonged postoperative analgesia in subjects undergoing open total abdominal hysterectomy.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: EXPAREL	Phase 4

Detailed Description

This is a prospective, open-label, non-randomized study with two treatment groups differing only in the volume of EXPAREL infiltrated into the TAP. All subjects will undergo an open total abdominal hysterectomy. The dose of EXPAREL for the TAPs will be the same for all 20 subjects, 133 mg on the right side of the abdomen and 133 mg on the left side of the abdomen.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Safety and Efficacy of EXPAREL(R) (Bupivacaine Liposome Injectable Suspension) When Administered Into the Transversus Abdominis Plane (TAP) for Prolonged Postoperative Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EXPAREL Group 1 EXPAREL 266 mg diluted with saline to a volume of 40 mL	Drug: EXPAREL; Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.; Other Names: Bupivacaine liposome injectable suspension
Experimental: EXPAREL Group 2 EXPAREL 266 mg diluted with saline to a volume of 60 mL	Drug: EXPAREL; Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.; Other Names: Bupivacaine liposome injectable suspension

Outcome Measures

Primary Outcome Measures

1. Duration of Analgesia [End of surgery to time of subject's first postsurgical opioid administration (through 72 hours)]

Secondary Outcome Measures

1. Incidence of Adverse Events [10 days post surgery plus or minus 3 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Females, 18-75 years of age inclusive.

• American Society of Anesthesiologist (ASA) physical status 1-3.

• Undergoing open total abdominal hysterectomy (i.e., laparoscopic procedures are not sufficient) without any concurrent surgical procedure(s).

• Physically and mentally able to participate in the study and complete all study assessments.

• Able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the TAP.

Exclusion Criteria:

• Demonstrated hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.

• Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a TAP.

• Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study.

• Any subject, who in the opinion of the Investigator, is on chronic pain medicine.

• Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pacira Pharmaceuticals, Inc

Investigators

• Principal Investigator: Robert Dorian, MD, St. Barnabas Medical Center, Livingston, NJ 07039
• Principal Investigator: Thad Denehy, MD, St. Barnabas Medical Center, Livingston, NJ 07039

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pacira Pharmaceuticals, Inc
• ClinicalTrials.gov Identifier: NCT01919606
• Other Study ID Numbers: MA402S23B703
• First Posted: Aug 9, 2013
• Last Update Posted: Mar 2, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Pacira Pharmaceuticals, Inc: hysterectomy; analgesia
• Additional relevant MeSH terms: Pain, Postoperative; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	EXPAREL Group 1	EXPAREL Group 2
Arm/Group Description	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 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.
Period Title: Overall Study
STARTED	1	0
COMPLETED	1	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	EXPAREL Group 1	EXPAREL Group 2	Total
Arm/Group Description	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 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 of all reporting groups
Overall Participants	1	0	1
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67 (0)	67 (0)
Age (Count of Participants)
<=18 years	0 0%	0 NaN
Between 18 and 65 years	0 0%	0 NaN
>=65 years	1 100%	1 Infinity
Sex: Female, Male (Count of Participants)
Female	1 100%	1 Infinity
Male	0 0%	0 NaN
Region of Enrollment (participants) [Number]
United States	1 100%	1 Infinity

Outcome Measures

1. Primary Outcome

Title	Duration of Analgesia
Time Frame	End of surgery to time of subject's first postsurgical opioid administration (through 72 hours)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EXPAREL Group 1	EXPAREL Group 2
Arm/Group Description	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 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.
Measure Participants	0	0

2. Secondary Outcome

Title	Incidence of Adverse Events
Time Frame	10 days post surgery plus or minus 3 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EXPAREL Group 1	EXPAREL Group 2
Arm/Group Description	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 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.
Measure Participants	1	0
Number [number of events]	0

Adverse Events

Time Frame	10 days post surgery plus or minus 3 days
Adverse Event Reporting Description	Normal systematic assessment for adverse events
Arm/Group Title	EXPAREL Group 1		EXPAREL Group 2
Arm/Group Description	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 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.
All Cause Mortality
	EXPAREL Group 1		EXPAREL Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	EXPAREL Group 1		EXPAREL Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	EXPAREL Group 1		EXPAREL Group 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.