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Study of Postoperative Analgesia in Bunionectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00890682
Recruitment Status : Completed
First Posted : April 30, 2009
Results First Posted : August 5, 2013
Last Update Posted : August 5, 2013
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc

Tracking Information
First Submitted Date  ICMJE April 28, 2009
First Posted Date  ICMJE April 30, 2009
Results First Submitted Date  ICMJE November 21, 2011
Results First Posted Date  ICMJE August 5, 2013
Last Update Posted Date August 5, 2013
Study Start Date  ICMJE April 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2013)
Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores [ Time Frame: 0-24 hours ]
The AUC of the NRS-R pain intensity scores from time 0 through 24 hours The subject was to rest for at least 5 minutes before responding to the following question, "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain are you having right now?"
Original Primary Outcome Measures  ICMJE
 (submitted: April 28, 2009)
The primary outcome measure is the area under the curve (AUC0-24) of the numeric rating scale (NRS) pain intensity scores through 24 hours for subjects receiving SKY0402 vs. placebo [ Time Frame: 72 hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2013)
Adverse Event Profile [ Time Frame: 30 days ]
Participants with an Adverse Event through 72 hours or a Serious Adverse Event through 30 days
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Study of Postoperative Analgesia in Bunionectomy
Official Title  ICMJE A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing First Metatarsal Osteotomy (Bunionectomy)
Brief Summary After undergoing bunion surgery, patients are given a pain medicine injection that may last for up to several days or a placebo. Their pain and pain medicine use is then monitored.
Detailed Description Following drug study administration, safety and efficacy assessments were conducted
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Bunion
  • Hallux Valgus
Intervention  ICMJE
  • Drug: SKY0402
    Local infiltration of 8cc SKY0402
    Other Name: EXPAREL
  • Drug: Placebo
    Local infiltration of 8cc Placebo
    Other Name: saline 0.9%
Study Arms  ICMJE
  • Experimental: Sky0402
    Injection of Study Drug
    Intervention: Drug: SKY0402
  • Placebo Comparator: Placebo
    Injection of study drug
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 27, 2010)
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2009)
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years at the Screening visit
  • Scheduled to undergo primary unilateral first metatarsal osteotomy without hammertoe
  • Female subjects must be surgically sterile or at least two years menopausal, or using an acceptable method of birth control. If of childbearing potential, have a documented negative blood or urine pregnancy test within 24 hours before surgery
  • Clinical laboratory values less than or equal to twice the upper limit of normal or, if abnormal, deemed not clinically significant per the Investigator
  • Ability to provide informed consent, adhere to the study visit schedule and complete all study assessments

Exclusion Criteria:

  • Currently pregnant, nursing, or planning to become pregnant during the study or within one month after study drug administration
  • Chronic user of analgesic medications, including taking opioid medications for more than 14 days in the last 3 months, or non-opioid pain medications more than 5 times per week
  • Use of any non-steroidal anti-inflammatory drug (NSAID) including selective COX-2 inhibitor within three days of surgery
  • Use of acetaminophen within 24 hours of surgery
  • Use of selective serotonin reuptake inhibitors (SSRIs), gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) within three days of surgery
  • Current use of systemic glucocorticosteroids or use of systemic glucocorticoids within one month of enrollment into this study
  • Peripheral neuropathy including diabetic neuropathy, chemotherapy-induced neuropathy, HIV neuropathy
  • History of hepatitis
  • History of, suspected, or known addiction to or abuse of drugs or alcohol within the past two years
  • Failure to pass urine drug screen
  • Current evidence of alcohol abuse (greater than 4 units of alcohol per day: 1 unit = ½ pint of beer, 1 glass of wine or 1 oz. of spirits)
  • Evidence of peripheral ischemic disease
  • Type I or Type II diabetes
  • Current acute or chronic medical or major psychiatric disease that, in the opinion of the Investigator, would interfere with the evaluation of study drug efficacy or safety
  • Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix
  • Administration of an investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
  • Previous participation in a SKY0402 study
  • Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures
  • Current painful physical conditions or concurrent surgery other than bunionectomy that may require analgesic treatment (such as NSAID or opioid) in the postoperative period for pain that is not strictly related to the bunionectomy procedure and may confound the postoperative assessments
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00890682
Other Study ID Numbers  ICMJE SKY0402C317
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pacira Pharmaceuticals, Inc
Study Sponsor  ICMJE Pacira Pharmaceuticals, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen Daniels, DO Premier Research Group Clinical Research Center
PRS Account Pacira Pharmaceuticals, Inc
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP