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

NCT00813111 | Terminated Phase 3 Results

• 1 other identifier: SIMPLE Breast Augmentation 315
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 15

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.

Conditions

Pain

Keywords

Postsurgical pain; Analgesia; Breast augmentation

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores

  Assessments of postoperative pain included pain intensity at rest (using the NRS at rest \[NRS-R\] and with activity \[using the NRS-A\]) where the prescribed activity was raising both arms. Pain intensity was assessed on a scale of 0 to 10, where 0=no pain and 10=worst possible pain.

  through 72 hours

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  30 days

Study Arms (2)

SKY0402

EXPERIMENTAL

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)

Drug: SKY0402

Bupivacaine HCl

ACTIVE COMPARATOR

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)

Drug: Bupivacaine HCl

Interventions

SKY0402 DRUG

600mg SKY0402 instilled into breast pocket during surgery

Also known as: EXPAREL

SKY0402

Bupivacaine HCl DRUG

200mg Bupivacaine HCl instilled into breast pocket during surgery

Also known as: Marcaine 0.5% with epinephrine

Bupivacaine HCl

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women greater than or equal to 18 years of age at Screening Visit
• 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.
• Scheduled to undergo primary, bilateral, cosmetic, sub-muscular, breast augmentation under general anesthesia (endotracheal or otherwise)
• American Society of Anesthesiologist (ASA) Physical Class 1-4
• Able and willing to comply with all study visits and procedures, and with diary entries through postoperative day 8
• 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
• Willing and capable of providing written informed consent.

You may not qualify if:

• A subject will not be eligible for the study if she meets any of the following criteria:
• Women undergoing reconstructive surgery following mastectomy
• Pregnancy, nursing, or planning to become pregnant during the study or within one month after study drug administration.
• Use of any of the following medications within the times specified before surgery:
• long-acting opioids within 3 days.
• Any opioid medication within 24 hours.
• 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.
• Body weight less than 50 kilograms (110 pounds)
• History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics, opioid medication, epinephrine, or sulfites.
• 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.
• 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.
• History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
• Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance with the protocol.
• 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:

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (15)

West Alabama Research, LLC.

Birmingham, Alabama, 35209, United States

Location

West Alabama Research, LLC

Birmingham, Alabama, 35209, United States

Location

Horizon Research Group, Inc

Mobile, Alabama, 36608, United States

Location

La Jolla Spa MD

La Jolla, California, 90237, United States

Location

Associates for Plastic Surgery Medical Group, Inc.

La Jolla, California, 92037, United States

Location

Lotus Clinical Research

Pasadena, California, 91105, United States

Location

Pacific Plastic Surgery

Santa Barbara, California, 93105, United States

Location

Miami Plastic Surgery

Miami, Florida, 33176, United States

Location

North Fulton Plastic Surgery

Roswell, Georgia, 30076, United States

Location

Waldman and Schantz Plastic Surgery

Lexington, Kentucky, 40508, United States

Location

Back Bay Plastic Surgery

Boston, Massachusetts, 02116, United States

Location

Personal Enhancement Center

Toms River, New Jersey, 08753, United States

Location

The Ohio State University Research Foundation

Columbus, Ohio, 43210, United States

Location

Research Concepts, Ltd

Bellaire, Texas, 77402, United States

Location

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

University Park, Texas, 75205, United States

Location

Related Publications (1)

• 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.

  PMID: 22900785 DERIVED

MeSH Terms

Conditions

Pain; Pain, Postoperative; Agnosia

Interventions

Bupivacaine; Epinephrine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Executive Medical Director
• Organization: Pacira Pharmaceuticals, Inc.

ErolOnel@pacira.com

203-837-6500

Study Officials

• Kay Warnott, RN

  Pacira Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 22, 2008
• Study Start: November 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: January 16, 2014
• Results First Posted: January 16, 2014

Record last verified: 2013-11

Locations

US (15)