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

Pacira

Status and phase

Terminated

Phase 4

Conditions

Postoperative Pain

Treatments

Drug: EXPAREL

Study type

Interventional

Funder types

Industry

Identifiers

NCT01919606

MA402S23B703

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.