Phase 3 Study of Local Administration of SKY0402 for Postoperative Analgesia in Subject Undergoing Breast Augmentation

NCT ID: NCT00813111

Last Updated: 2014-01-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-02-28

Brief Summary

The purpose of this study is to provide a more effective postoperative method of pain control for patients undergoing cosmetic sub-muscular breast augmentation. Appropriate postoperative pain management contributes to faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

Detailed Description

This is a phase 3 study conducted to evaluate the safety and efficacy of a single local administration of 300 mg of SKY0402 compared with 100 mg of conventional, commercially-available bupivacaine HCl (i.e. Marcaine 0.5% with epinephrine) administered locally into the implant pocket of each breast for postoperative analgesia in subjects undergoing bilateral, cosmetic, sub-muscular, breast augmentation under general anesthesia (endotracheal or otherwise). A total of 600 mg of SKY0402 or 200 mg bupivacaine HCl per subject is therefore administered. Post-operative assessments were conducted including adverse event and serious adverse event monitoring through Day 30.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

SKY0402

A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)

Group Type: EXPERIMENTAL

SKY0402

Intervention Type: DRUG

600mg SKY0402 instilled into breast pocket during surgery

Bupivacaine HCl

A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)

Group Type: ACTIVE_COMPARATOR

Bupivacaine HCl

Intervention Type: DRUG

200mg Bupivacaine HCl instilled into breast pocket during surgery

Interventions

SKY0402

600mg SKY0402 instilled into breast pocket during surgery

Intervention Type: DRUG

Bupivacaine HCl

200mg Bupivacaine HCl instilled into breast pocket during surgery

Intervention Type: DRUG

Other Intervention Names

EXPAREL; Marcaine 0.5% with epinephrine

Eligibility Criteria

Inclusion Criteria

1. Women greater than or equal to 18 years of age at Screening Visit

2. Postmenopausal, surgically sterile, or willing to use acceptable means of contraception for at least 30 days after surgery including any of the following: hormonal contraceptives (e.g., oral, injectable, implantable starting at least 30 days before study administration), effective double-barrier methods (e.g., condoms with spermicide), intrauterine device, lifestyle with a personal choice of abstinence, nonheterosexual lifestyle, or a strictly monogamous relationship with a partner who has had a vasectomy.

3. Scheduled to undergo primary, bilateral, cosmetic, sub-muscular, breast augmentation under general anesthesia (endotracheal or otherwise)

4. American Society of Anesthesiologist (ASA) Physical Class 1-4

5. Able and willing to comply with all study visits and procedures, and with diary entries through postoperative day 8

6. Able to speak, read, and understand the language of the informed consent form (ICF), study questionnaires, and other instruments used for collecting subject-reported outcomes, in order to enable accurate and appropriate responses to pain scales and other required study assessments

7. Willing and capable of providing written informed consent.

Exclusion Criteria

A subject will not be eligible for the study if she meets any of the following criteria:

1. Women undergoing reconstructive surgery following mastectomy

2. Pregnancy, nursing, or planning to become pregnant during the study or within one month after study drug administration.

3. Use of any of the following medications within the times specified before surgery:

1. long-acting opioids within 3 days.

2. Any opioid medication within 24 hours.

4. Concurrent painful physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain that is not strictly related to the surgical site being administered study drug (e.g., significant pain from other joints, chronic neuropathic pain, concurrent abdominal surgery, etc.), which have the potential to confound the postoperative study assessments.

5. Body weight less than 50 kilograms (110 pounds)

6. History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics, opioid medication, epinephrine, or sulfites.

7. Contraindication to epinephrine, such as concurrent administration of ergot-type drugs, monoamine oxidase (MAO) inhibitors or antidepressants of tryptoline or imipramine types, conditions where the production or exacerbation of tachycardia could provide fatal (e.g., poorly controlled thyrotoxicosis or severe heart disease) or any other pathological conditions that might be aggravated by the effect of epinephrine.

8. Administration of investigational product within 30 days of 5 elimination half-lives of such investigational product, whichever is longer, prior to study drug administration or planned administration of another investigational product or procedure during the subject's participation in this study.

9. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.

10. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance with the protocol.

11. Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures, and expose the subject to an unreasonable risk as a result of participating in this clinical trial, such as: debilitating diseases, acute illnesses, hypotension, partial or complete conduction block, impaired cardiac function, untreated hypertension, advanced arteriosclerotic heart disease, cerebral vascular insufficiency, pre-existing abnormal neurological or neuromuscular disease (e.g., epilepsy, myasthenia gravis), advanced liver disease, severe renal impairment, advanced diabetes, co-morbid conditions associated with an immunocompromised status such as blood dyscrasias, HIV/AIDS, or recent chemotherapy.

In addition, the subject will be ineligible to receive study drug if she meets the following criteria during surgery:

12. Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postoperative course.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kay Warnott, RN

Role: STUDY_DIRECTOR

Pacira Pharmaceuticals, Inc

Locations

West Alabama Research, LLC.

Birmingham, Alabama, United States

West Alabama Research, LLC

Birmingham, Alabama, United States

Horizon Research Group, Inc

Mobile, Alabama, United States

La Jolla Spa MD

La Jolla, California, United States

Associates for Plastic Surgery Medical Group, Inc.

La Jolla, California, United States

Lotus Clinical Research

Pasadena, California, United States

Pacific Plastic Surgery

Santa Barbara, California, United States

Miami Plastic Surgery

Miami, Florida, United States

North Fulton Plastic Surgery

Roswell, Georgia, United States

Waldman and Schantz Plastic Surgery

Lexington, Kentucky, United States

Back Bay Plastic Surgery

Boston, Massachusetts, United States

Personal Enhancement Center

Toms River, New Jersey, United States

The Ohio State University Research Foundation

Columbus, Ohio, United States

Research Concepts, Ltd

Bellaire, Texas, United States

Office of Dr. William P. Adams, Jr., MD

University Park, Texas, United States

Countries

United States

References

Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.

Reference Type: DERIVED

PMID: 22900785 (View on PubMed)

Other Identifiers

SIMPLE Breast Augmentation 315

Identifier Type: -

Identifier Source: org_study_id