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

NCT01919606 | Terminated Phase 4 Results

• 1 other identifier: MA402S23B703
• Study Type: interventional
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pain

Keywords

hysterectomy; analgesia

Outcome Measures

Primary Outcomes (1)

• Duration of Analgesia

  End of surgery to time of subject's first postsurgical opioid administration (through 72 hours)

Secondary Outcomes (1)

• Incidence of Adverse Events

  10 days post surgery plus or minus 3 days

Study Arms (2)

EXPAREL Group 1

EXPERIMENTAL

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

Drug: EXPAREL

EXPAREL Group 2

EXPERIMENTAL

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

Drug: EXPAREL

Interventions

EXPAREL DRUG

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

Also known as: Bupivacaine liposome injectable suspension

EXPAREL Group 1; EXPAREL Group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Pacira Medical Information
• Organization: Pacira Pharmaceuticals, Inc.

MedInfo@pacira.com

1-855-793-9727

Study Officials

• Robert Dorian, MD

  St. Barnabas Medical Center, Livingston, NJ 07039

  PRINCIPAL INVESTIGATOR

• Thad Denehy, MD

  St. Barnabas Medical Center, Livingston, NJ 07039

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: August 9, 2013
• Study Start: August 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 2, 2021
• Results First Posted: May 14, 2014

Record last verified: 2021-02