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

NCT ID: NCT01919606

Last Updated: 2021-03-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2012-10-31

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.

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EXPAREL Group 1

EXPAREL 266 mg diluted with saline to a volume of 40 mL

Group Type: EXPERIMENTAL

EXPAREL

Intervention Type: DRUG

Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.

EXPAREL Group 2

EXPAREL 266 mg diluted with saline to a volume of 60 mL

Group Type: EXPERIMENTAL

EXPAREL

Intervention Type: DRUG

Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.

Interventions

EXPAREL

Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.

Intervention Type: DRUG

Other Intervention Names

Bupivacaine liposome injectable suspension

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Dorian, MD

Role: PRINCIPAL_INVESTIGATOR

St. Barnabas Medical Center, Livingston, NJ 07039

Thad Denehy, MD

Role: PRINCIPAL_INVESTIGATOR

St. Barnabas Medical Center, Livingston, NJ 07039

Other Identifiers

MA402S23B703

Identifier Type: -

Identifier Source: org_study_id