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

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

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.

Study Overview

• Status: Terminated
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: EXPAREL

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: February 26, 2013
• First Submitted That Met QC Criteria: August 7, 2013
• First Posted (Estimate): August 9, 2013

Study Record Updates

• Last Update Posted (Actual): March 2, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: analgesia; hysterectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: MA402S23B703