Clinical trial NCT01919606: EXPAREL Administered Into the TAP for Analgesia in Subjects Undergoing Open Total Abdominal Hysterectomy
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: hysterectomy
analgesia
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2013-08-09
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Duration of Analgesia
timeFrame: End of surgery to time of subject's first postsurgical opioid administration (through 72 hours)
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: 10 days post surgery plus or minus 3 days
Other outcomes:
Locations:
Study officials:
affiliation: St. Barnabas Medical Center, Livingston, NJ 07039
name: Robert Dorian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Barnabas Medical Center, Livingston, NJ 07039
name: Thad Denehy, MD
role: PRINCIPAL_INVESTIGATOR
References: